Surgical stapler for aortic anastomosis

ABSTRACT

A method for connecting a graft vessel to a target vessel may involve advancing a guidewire of a surgical stapler into the target vessel through an opening at a first location on the target vessel, coupling a stapler cartridge carrying the graft vessel with an anvil of the surgical stapler, activating the anvil to staple the graft vessel to the target vessel at a second location on the target vessel, removing the guidewire from the target vessel, and closing the opening in the target vessel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to commonly owned Provisional PatentApplication No. 61/531,130, filed Sep. 9, 2011, which application ishereby incorporated herein by reference in its entirety and from whichapplication priority is hereby claimed under 35 U.S.C. §119(e).

BACKGROUND

1. Field of the Invention

The invention relates to a surgical apparatus and method for performinganastomosis.

2. Background

Anastomosis is a procedure by which two hollow tissue structures arejoined together. More particularly, vascular anastomosis is a procedureby which two blood vessels within a patient are surgically joinedtogether. Vascular anastomosis is performed during treatment of avariety of conditions including coronary artery disease, diseases of thegreat and peripheral vessels, organ transplantation, and trauma. Incoronary artery disease (CAD), for example, an occlusion or stenosis ina coronary artery interferes with blood flow to the heart muscle.Treatment of CAD sometimes involves attaching a graft, in the form of aprosthesis or harvested artery or vein, to one or more of the coronaryarteries to reroute blood flow around the occlusion and restore adequateblood flow to the heart muscle. This treatment is known as coronaryartery bypass grafting (CABG).

In a conventional CABG procedure, a large incision is made in the chest,and the sternum is sawed in half to allow access to the heart. Inaddition, a heart-lung machine is used to circulate the patient's bloodso that the heart can be stopped and the anastomosis can be performed.In order to minimize the trauma to the patient induced by conventionalCABG, less invasive techniques have been developed in which the surgeryis performed through small incisions in the patient's chest with the aidof visualizing scopes. In both conventional and less invasive CABGprocedures, the surgeon has to suture one end of the graft vessel to thecoronary artery and the other end of the graft vessel to ablood-supplying artery, such as the aorta. The suturing process is atime consuming and difficult procedure requiring a high level ofsurgical skill. In order to perform the suturing of the graft to atarget vessel, such as the coronary artery, a surgeon holds the edges ofthe incision in the target vessel with one hand and holds a needle inthe other hand for suturing, or an assistant may hold the edges of theincision in the target vessel while a surgeon makes small stitches asclose as possible to the edges of the incision. In addition, duringconventional CABG procedures, blood flow at the anastomosis site isstopped during suturing. This prevents bleeding from the incision sitebut also prevents blood from reaching a portion of the heart muscleserved by the vessel. Further, during off-pump CABG procedures a sideclamp or other device may be used to isolate a portion of the wall ofthe aorta to which a graft vessel is sutured. The use of a side clamp orsimilar device can cause emboli to detach from the wall of the aorta andenter the bloodstream, which is undesirable.

To address these challenges, surgical stapling devices and method havebeen developed for use in CABG procedures. The assignee of the presentapplication, for example, has developed a number of such devices andmethods, such as those described, for example, in U.S. Pat. No.7,682,368, which is hereby incorporated by reference in its entirety.

In another example of an anastomosis procedure, a graft may also beplaced on an aorta for a number of different reasons. In CABGprocedures, the blood pressures and blood flows encountered in coronaryarteries are typically both quite low, due to the occluded state of thecoronary arteries being operated on. Also, coronary arteries arerelatively small-diameter blood vessels. In contrast, blood pressure andblood flow in the aorta are typically quite high, and the aorta is muchlarger than the coronary arteries. Due at least in part to the highpressures and flows encountered in the aorta, surgical staples have notbeen used previously in anastomosis procedures involving the aorta.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an anvil and a plurality of staplesaccording to a first aspect of the present invention.

FIG. 2 is a perspective view of the anvil of FIG. 1 being inserted intoa target vessel.

FIG. 3 is a perspective view of the anvil tenting a wall of a targetvessel for an anastomosis procedure.

FIG. 4 is a perspective view of a graft vessel placed adjacent anexterior of the tented target vessel for the anastomosis procedure.

FIG. 5 is a perspective view of the staples being applied to the graftvessel and the target vessel during an anastomosis procedure.

FIG. 6 is a perspective view of the completed anastomosis according tothe first aspect of the present invention.

FIG. 7 is a perspective view of a staple supported on a staple holdingstrip.

FIG. 8 is a side view of the staple and staple holding strip of FIG. 7when the ends of the staple have been bent by contact with an anvil.

FIG. 9 is a perspective view of an anvil and staple according to anotheraspect of the present invention.

FIGS. 10A and 10B are side views of a plurality of staples supported ontwo examples of expandable staple holding strips.

FIG. 11 is a perspective view of a portion of an anvil having a movablecutting device.

FIG. 12 is a side view of an anvil having an external cutting device.

FIGS. 12A and 12B are side views of a portion of an anvil and twocutting devices that snap onto the anvil.

FIG. 13 is a side view of a portion of an anvil with an extendablecutting device.

FIG. 14 is a side view of the anvil of FIG. 13 with the cutting deviceextended.

FIG. 15 is a side view of a portion of an anvil with an alternateextendable cutting device.

FIG. 16 is a side view of the anvil of FIG. 15 with the cutting deviceextended.

FIG. 17 is a perspective view of an anvil according to a second aspectof the invention being inserted into a target vessel.

FIG. 18 is a perspective view of the anvil of FIG. 17 positioning insidea target vessel and a clamp being advanced to clamp the wall of thetarget vessel between the anvil and the clamp.

FIG. 19 is a perspective view of a graft vessel being advanced to thetarget vessel with a continuous anastomosis staple while the anastomosissite on the target vessel is controlled by the anvil and clamp.

FIGS. 20-22 are side cross sectional views of the steps of performingthe anastomosis with the continuous anastomosis staple shown in FIG. 19.

FIG. 23 is a perspective view of the completed anastomosis performed asshown in FIGS. 19-22.

FIGS. 24-27 are perspective views of the steps of an alternative anviland clamp system for controlling an anastomosis site and forming anincision through the clamped tissue of the target vessel.

FIG. 28 is a perspective view of a system for controlling a tissue siteand performing anastomosis according to the present invention.

FIG. 29 is a cross sectional view taken along line C-C of FIG. 28,showing a first step of the anastomosis procedure.

FIG. 30 is a cross sectional view taken along line C-C of FIG. 28,showing a second step of the anastomosis procedure.

FIG. 31 is a cross sectional view taken along line C-C of FIG. 28,showing a third step of the anastomosis procedure.

FIG. 32 is a perspective view of an anvil according to another aspect ofthe present invention for use with sutures.

FIG. 33 is a perspective view of the anvil of FIG. 32 positioned withina target vessel and used to locate a plurality of suture at ananastomosis site.

FIG. 34 is a side cutaway view of a first embodiment of an anvil, acutter and a staple holder, where the anvil and staple holder are spacedapart from each other.

FIG. 35 is an end cross-section view of the anvil of FIG. 34.

FIG. 36 is a side cutaway view of a portion of the anvil inserted intothe lumen of a target vessel.

FIG. 37 is a side view of the cutter.

FIG. 38 is a perspective view of the cutter of FIG. 37.

FIG. 39 is a side view of the distal end of a second embodiment of acutter.

FIG. 40 is a side view of the distal end of a third embodiment of acutter.

FIG. 41 is a side view of the distal end of a fourth embodiment of acutter.

FIG. 42 is a side view of a portion of a fifth embodiment of a cutter.

FIG. 43 is a side view of the distal end of a sixth embodiment of acutter.

FIG. 43A is a side view of another embodiment of a cutter.

FIG. 43B is a side view of another embodiment of a cutter.

FIG. 44 is a side cutaway view of the anvil and staple holder of FIG.34, where the cutter is in a first position.

FIG. 45 is a side cutaway view of the anvil and staple holder of FIG.34, where the cutter is in a second position.

FIG. 46 is a side cutaway view of the anvil and staple holder of FIG.34, where the cutter is in a third position.

FIG. 47 is a side cutaway view of the anvil and staple holder of FIG.34, where the cutter is in a fourth position.

FIG. 48 is a side cutaway view of the anvil and staple holder of FIG.34, where the cutter is in a fifth position.

FIG. 49 is a side cutaway view of a second embodiment of an anvil and astaple holder, where the anvil and staple holder are spaced apart fromeach other.

FIG. 50 is a side cutaway view of the anvil and staple holder of FIG.40, where the cutter is in a first position.

FIG. 51 is a side cutaway view of the anvil and staple holder of FIG.40, where the cutter is in a second position.

FIG. 52 is a side cutaway view of the anvil and staple holder of FIG.40, where the cutter is in a third position.

FIG. 53 is a side cutaway view of the anvil and staple holder of FIG.40, where the cutter is in a fourth position.

FIG. 54 is a side cutaway view of the anvil and staple holder of FIG.40, where the cutter is in a fifth position.

FIG. 55 is a side view of an anastomosis tool having a tissue effectorand a handle.

FIG. 56 is a perspective view of the tissue effector of FIG. 55 in firstposition.

FIG. 57 is a perspective view of the tissue effector of FIG. 55 in asecond position.

FIG. 58 is another perspective view of the tissue effector of FIG. 55 inthe first position.

FIG. 59 is a perspective view of the tissue effector of FIG. 55 in thefirst position, with a graft vessel being connected to it.

FIG. 59A is a detail cross-section view of a cam lock used in the tissueeffector of FIG. 55, where the cam lock is in an open position.

FIG. 59B is a detail cross-section view of the cam lock of FIG. 59A in aclosed position.

FIG. 59C is an end view of the left half of the tissue effector of FIG.55, in the closed position.

FIG. 59D is an end view of the right half of another embodiment of thetissue effector of FIG. 55, in the closed position.

FIG. 60 is a detail side view of a portion of the tissue effector ofFIG. 55, showing an embodiment of a graft clip.

FIG. 61 is a detail end view of a portion of the tissue effector of FIG.55.

FIG. 62 is a side view of a vein knife used in the tissue effector ofFIG. 55.

FIG. 63 is a side view of a graft clip blade used in the tissue effectorof FIG. 55.

FIG. 64 is a cross-section view of section A-A of FIG. 57.

FIG. 65 is a perspective view of a connector deployer used in the arm ofFIG. 64.

FIG. 66 is a side view of a portion of the arm of FIG. 64 as defined bythe line B-B of FIG. 64.

FIG. 67 is a perspective view of a staple configured to be deployed fromthe tissue effector of FIG. 55.

FIG. 68 is a perspective view of a sled used in the tissue effector ofFIG. 55.

FIG. 69 is a bottom view of the sled of FIG. 68.

FIG. 69A is a side view of the sled of FIG. 68.

FIG. 70 is a side cross-section view of the handle of FIG. 55 in a firstposition.

FIG. 71 is a top view of a portion of a rocker utilized in the handle ofFIG. 55.

FIG. 72 is a side cross-section view of the handle of FIG. 55 in asecond position.

FIG. 73 is a perspective view of a completed anastomosis.

FIG. 74 is a perspective view of the tissue effector of FIG. 55 with agraft vessel loaded onto it.

FIG. 75 is a perspective view of the tissue effector of FIG. 74, wherethe anvil of the tissue effector has been inserted into the lumen of atarget vessel.

FIG. 76 is a perspective view of the tissue effector of FIG. 74, afterthe graft vessel has been connected to the target vessel and before theanvil of the tissue effector has been removed from the lumen of thetarget vessel.

FIG. 77 is a graph qualitatively illustrating the positions of thedistal slider and the proximal slider of the handle over time, withregard to an arbitrary point between them.

FIG. 78 is an exploded view of the handle of the anastomosis tool. Theuse of the same reference symbols in different figures indicates similaror identical items.

FIG. 79 is a perspective view of a retractor mount used in preparing agraft vessel for anastomosis.

FIG. 80 is a side cross-section view of the retractor mount of FIG. 79.

FIG. 80A is a perspective view of the retractor mount of FIG. 79 mountedon a standard surgical retractor.

FIG. 81 is a perspective view of a transfer clamp assembly used inpreparing a graft vessel for anastomosis, where the transfer clampassembly includes a transfer clamp and an extension arm.

FIG. 82 is an end view of the transfer clamp of FIG. 81 in an openposition.

FIG. 82a is a top cross-section view of the transfer clamp along thelines A-A of FIG. 82.

FIG. 83 is a perspective view of the transfer clamp of FIG. 81.

FIG. 84 is an end cross-section view of the transfer clamp of FIG. 81 inan open position, where cutting blocks are in a closed position relativeto the transfer clamp.

FIG. 85 is a side cross-section view of the transfer clamp of FIG. 81.

FIG. 86 is an end cross-section view of the transfer clamp of FIG. 81 inan open position, where cutting blocks are in an open position relativeto the transfer clamp.

FIG. 87 is a perspective view of a graft manipulator.

FIG. 88 is a perspective view of the transfer clamp of FIG. 81 holding agraft vessel.

FIG. 89 is a schematic side view of the graft vessel held within thetransfer clamp.

FIG. 90 is a perspective view of the transfer clamp of FIG. 81 holding agraft vessel, at the end of which flaps have been formed.

FIG. 91 is a perspective view of the transfer clamp of FIG. 81 holding agraft vessel, with cutting blocks in an open position.

FIG. 92 is a perspective view of an anastomosis tool connected to theretractor mount of FIG. 79.

FIG. 93 is a perspective view of an anvil of a tissue effector, to whicha shield is connected. The staple holder has been omitted from thetissue effector for clarity.

FIG. 94 is a side view of the anvil and shield of FIG. 93.

FIG. 95 is a side cross-section view of the anvil and shield of FIG. 93.

FIG. 96 is a perspective view of a sealer that is detachably connectedto the anvil.

FIG. 97 is a schematic view of the deployment of the sealer of FIG. 96.

FIG. 98 is a schematic view of another embodiment of a sealer prior toits deployment.

FIG. 99 is a schematic view of the sealer of FIG. 98 after deployment.

FIG. 100 is a schematic view of another embodiment of a sealer prior toits deployment.

FIG. 101 is a schematic view of the sealer of FIG. 100 after deployment.

FIG. 102 is a schematic view of another embodiment of a sealer prior toits deployment.

FIG. 103 is a schematic view of the sealer of FIG. 102 after deployment.

FIG. 104 is a schematic view of another embodiment of a sealer afterdeployment.

FIG. 105 is a schematic view of another embodiment of a sealer prior toits deployment.

FIG. 106 is a detail perspective view of a tissue effector with a sealerdetachably connected thereto, where the tissue effector includes ashield connected to the staple holder.

FIG. 107 is a side view of an exemplary clip used to seal the anvilentry hole adjacent to the anastomosis site, where that clip is securedto tissue.

FIG. 108 is a perspective view of the clip of FIG. 107.

FIG. 109 is a perspective view of another embodiment of a clip, prior toits release. The anvil and staple holder are not shown for clarity.

FIG. 110 is a perspective view of the clip of FIG. 109 after itsrelease.

FIG. 111 is a perspective view of a tissue effector configured to deployuser-selectable number of connectors.

FIG. 112 is a perspective view of the underside of the tissue effectorof FIG.

FIG. 113 is a side cross-section view of the tissue effector of FIG.111.

FIG. 114 is a perspective view of a split deployer used in the tissueeffector of FIG. 111.

FIG. 115 is a side cross-section view of an embodiment of the tissueeffector including another embodiment of a cutter, where the cutter isin a first position.

FIG. 116 is a side cross-section view of the tissue effector of FIG.115, where the cutter is in a second position.

FIG. 117 is a side cross-section view of the tissue effector of FIG.115, where the cutter is in a third position.

FIG. 118 is a side cross-section view of the tissue effector of FIG.115, where the cutter is in a fourth position.

FIG. 119 is a side cross-section view of an embodiment of the tissueeffector including another embodiment of a cutter, where the cutter isin a first position.

FIG. 120 is a side cross-section view of the tissue effector of FIG.119, where the cutter is in a second position.

FIG. 121 is a side cross-section view of the tissue effector of FIG.119, where the cutter is in a third position.

FIG. 122 is a side cross-section view of the tissue effector of FIG.119, where the cutter is in a fourth position.

FIG. 123 is a detail perspective view of a location near distal end ofthe tissue effector, where the bending features are located on an uppersurface of the anvil arm, and where the bending features correspondingto the toe of the anastomosis are offset toward one another.

FIG. 124 is a different detail perspective view of the tissue effectorof FIG. 123.

FIG. 125 is a side cross-section view of an embodiment of the tissueeffector including another embodiment of a cutter, where the cutter isin a first position.

FIG. 126 is a side cross-section view of the tissue effector of FIG.125, where the cutter is in a second position.

FIG. 127 is a side cross-section view of the tissue effector of FIG.125, where the cutter is in a third position.

FIG. 128 is a side cross-section view of the tissue effector of FIG.125, where the cutter is in a fourth position.

FIG. 129 is a perspective view of an embodiment of a sealer.

FIG. 130 is a perspective view of an embodiment of a tissue effectorthat includes a graft affixer connected to the staple holder.

FIG. 131 is a side cross section view of the staple holder of FIG. 130,where the tissue effector is in the open position.

FIG. 132 is a side cross-section view of the staple holder of FIG. 130,where the tissue effector is in the closed position.

FIG. 133 is a perspective view of a graft vessel prepared for use withthe tissue effector of FIG. 130.

FIG. 134 is a perspective view of the tissue effector of FIG. 130, witha graft vessel affixed thereto.

FIG. 135 is a perspective view of a completed anastomosis performed withthe tissue effector of FIG. 130 and the graft vessel of FIG. 134.

FIG. 136 is a perspective view of an exemplary applier that may be usedto apply a clip to the anvil entry hole.

FIG. 137 is a top view of a clip that may be used with the applier ofFIG. 136, where that clip in is an open position.

FIG. 138 is a top view of the clip of FIG. 137 in a closed position.

FIG. 139 is a perspective view of the applier of FIG. 136 in use.

FIG. 140 is a perspective view of an exemplary anastomosis tool.

FIG. 141 is a detail view of an exemplary articulated shaft.

FIG. 142 is a perspective view of an exemplary anastomosis tool.

FIG. 143 is a detail cutaway view of an exemplary anvil and cutter of ananastomosis tool.

FIG. 144 is a perspective view of the distal end of an exemplaryanastomosis tool, showing a graft vessel attached to the tissue effectorof that tool.

FIG. 145 is a cross-section of an exemplary staple holder of a tissueeffector, showing the relationship between a shield connected to thestaple holder and the graft vessel.

FIG. 146 is a top view of a tissue effector having a deploymentindicator.

FIG. 147 is a perspective view of another exemplary embodiment of a sled482.

FIG. 148 is a perspective cutaway view of an exemplary fluid-drivenactuator within the handle of an anastomosis tool.

FIG. 149 is a schematic view of an exemplary fluid-driven actuator in afirst, resting state.

FIG. 150 is a schematic view of an exemplary fluid-driven actuator in asecond, clamping state.

FIG. 151 is a schematic view of an exemplary fluid-driven actuator in athird, firing state.

FIG. 152 is a cross-section view of a distal portion of an exemplaryhandle of an anastomosis tool.

FIG. 153 is a cross-section view of a proximal portion of an exemplaryhandle of the anastomosis tool of FIG. 142.

FIG. 154 is a cross-section view of an exemplary tissue effector of theanastomosis tool of FIG. 142.

FIG. 155 is a perspective view of an exemplary tissue effector of theanastomosis tool of FIG. 142 in a graft preparation position.

FIG. 156 is a cutaway view of a connector bay in the staple holdershowing an exemplary connector deployer.

FIG. 157 is a top view of an exemplary clip used to seal the anvil entryhole adjacent to the anastomosis site, in an open configuration.

FIG. 158 is a side cross-section view of the clip of FIG. 157 held by anexemplary applier, where that applier is in a first position.

FIG. 159 is a side cross-section view of the clip of FIG. 157 held bythe applier of FIG. 158, where that applier is in a second position.

FIG. 160 is a side view of the clip of FIG. 157 in a closedconfiguration in the tissue of the target vessel.

FIG. 161 is a side view of an exemplary heel clip detachably connectedto the staple holder, in an open position.

FIG. 162 is a side view of the exemplary heel clip of FIG. 161detachably connected to the staple holder, after it has been deformed toa closed position.

FIG. 163 is a schematic view of a pressure regulation assembly in afirst state.

FIG. 164 is a schematic view of a pressure regulation assembly in asecond state.

FIG. 165 is a schematic view of a pressure regulation assembly in athird state.

FIG. 166A is a side view of a surgical stapler for aortic anastomosis,according to one embodiment.

FIG. 166B is a perspective view of a stapler cartridge for use with thesurgical stapler of FIG. 166A, according to one embodiment.

FIG. 167 is a perspective view of a graft loading device coupled with astapler cartridge, according to one embodiment.

FIGS. 168A-168E are perspective views of the graft loading device andstapler cartridge of FIG. 167, illustrating a method for loading a graftonto the cartridge, according to one embodiment.

FIG. 169 is a perspective view of the graft loading device and staplercartridge of FIG. 167, showing a graft loaded onto the cartridge,according to one embodiment.

FIGS. 170A-170J are perspective views of a portion of an aorta,illustrating a method for creating an anastomosis between a graft andthe aorta, using a surgical stapler, according to one embodiment.

The use of the same reference symbols in different figures indicatessimilar or identical items.

DETAILED DESCRIPTION

Anvil

As shown in FIG. 1, one embodiment of an anvil 10 includes a handle 12and an anvil arm 14 extending from the handle 12. The anvil arm 14 maybe oriented substantially perpendicular to the handle 12 or oriented ata different angle. The anvil arm 14 may be provided with one or morestaple bending features 16 on opposite sides of the anvil arm 14. In theanvil 10 shown in FIG. 1, the staple bending features 16 each include aplurality of recesses 20 which receive the ends of staples 22 and causethe staple ends to bend over. At least one of the staple bendingfeatures 16 may be configured differently or omitted, if desired. Thestaples 22 may be connected to a staple holding strip 24. The staples 22are U-shaped and are arranged in a spaced apart parallel configurationsuch that the staples 22 all lie in a single plane. Alternately, thestaples 22 may be shaped differently, and/or lie in one or moredifferent planes. An exemplary anvil arm 14 has a height and a width ofabout 2 mm or less, advantageously about 1 mm or less, and a length ofabout 2 to 15 mm, advantageously 5 to 12 mm. The length of the anvilwill vary depending on the diameter of the graft vessel selected. Thelength to width ratio of the anvil arm 14 is substantially between 2:1and 15:1. A different length to width ratio may be used, if desired. Asone example, the staples 22 have widths of about 0.2-3 mm.Advantageously, the staples 22 have widths of substantially 2 mm orless. The leg lengths of the staples 22 are substantially 0.2-3 mm.Alternately, other staple widths and/or leg lengths may be used.

The anvil arm 14 has a sharp distal end 28 for puncturing the tissue ofa target vessel to insert the anvil arm 14 into the target vessel. Asillustrated in FIG. 2, the anvil arm 14 is inserted into a pressurizedor unpressurized target vessel 30 by puncturing the target vessel withthe distal end 28 of the anvil arm 14. The hole that is formed in thewall of the target vessel 30 by the anvil arm 14 is small enough toprevent significant bleeding through the puncture site. Alternately, thehole is closed by hand suturing. Alternately, the hole is closed with abiocompatible glue, adhesive or the like. Alternately, the hole isclosed with a clip, clamp, or other implantable device that remains onthe target vessel, as described in greater detail below. Such a devicemay be positioned on the outer surface and/or inner surface of thetarget vessel, and may extend into the hole. A device for closing thehole may be constructed from nitinol or other superelastic orpseudoelastic material, or from stainless steel or other material, wherethat device moves between a first configuration and a secondconfiguration during deployment, and where the second configurationholds the hole closed. The hole is less than substantially 2 mm wide andadvantageously less than 1 mm wide. Alternately, the anvil arm 14 has ablunt distal end 28 that is inserted through a hole created with aseparate instrument, by a different instrument connected to the anvilarm 14, or by a sharp member connected to the anvil arm 14 that can beretracted into the anvil arm 14 or otherwise blunted or concealed afterpuncturing or creating an incision in the wall of the target vessel.

Once the anvil arm 14 has been inserted into the target vessel 30, theanvil arm 14 may be pulled against an inner wall of the target vessel30, causing tenting of the thin tissue of the vessel wall as illustratedin FIG. 3. This tenting of the vessel wall provides control over theanastomosis site during an anastomosis procedure that is described withrespect to FIGS. 4-6. However, the target vessel wall need not be tentedin order to control the anastomosis site during the anastomosisprocedure.

Staple Holder and Connectors

As shown in FIG. 4, a graft vessel 32 is advanced to the anastomosissite and an end 34 of the graft vessel 32 is positioned adjacent anexterior surface of the target vessel 30 at the anastomosis site. Atleast part of the tented portion of the target vessel 30 is positionedwithin the perimeter of the end 34 of the graft vessel 32. As shown inFIG. 5, a staple holder 38 is provided having two arms 40 which arepivotally connected to the handle 12 of the anvil 10. Alternatively, thepivoting arms 40 of the staple holder 38 may be connected to the handle12 in a different way, or may be connected to a separate or additionaldevice. The arms 40 are spaced apart from one another across at least apart of their length. Thus, the graft vessel can be positioned betweenthe arms 40. That is, the arms 40 are positioned on substantiallyopposite sides of the graft vessel. In this way, each arm 40 may bepositioned against a flap at an end of the graft vessel, as illustratedin FIGS. 29-31. The arms 40 may be configured differently, if desired.

Referring also to FIG. 1, the staple holder 38 may be used to holdindividual staples 22 and/or staple holding strips 24. In oneembodiment, each arm 40 of the staple holder 38 carries one row ofstaples 22 or one staple holding strip 24, where the staples 22 arearranged in a substantially linear row. Alternately, staples 22 orstaple strips 24 may be arranged in two or more rows, parallel orotherwise, on one or more arms 40. Alternately, the staples 22 may bestaggered on one or more arms, such that at least one row of staples 22does not fall along a straight line. Alternately, the staples 22 may bearranged in a nonlinear manner on at least one arm 40. The staples 22 orstaple strips 24 may be arranged or aligned in any manner on each arm 40that results in a secure anastomosis between the graft vessel and thetarget vessel. The staples 22 are inserted through the flaps at the endof the graft vessel 32, or another portion of the graft vessel, and intothe target vessel 30 by pivoting the arms 40 of the staple holder 38towards the anvil arm 14. The staple bending features 16 are positionedin a configuration corresponding to the configuration of the staples 22,such that each staple 22 engages a corresponding staple bending feature16 during deployment. When the ends of the staples 22 engage the staplebending features 16 on the anvil arm 14, the ends of the staples 22 arebent over, securing the graft vessel 32 and target vessel 30 together.Once the staple ends are bent over, the staples 22 are released from thestaple holding strip 24 or the staple holder 38, resulting in spacedapart staples 22 securing the graft vessel 32 and the target vessel 30together as shown in FIG. 6. Alternately, the staple holder 38 is amechanism that deploys connectors other than or in addition to staples22 and/or staple holding strips 24.

After stapling is complete, an incision is formed in the wall of thetarget vessel 30 to allow blood flow between the target vessel and thegraft vessel 32. Some examples of methods and devices for forming theincision will be described in further detail below. Alternately, theincision is formed in the wall of the target vessel 30 before, or while,stapling is performed. FIG. 6 illustrates a completed anastomosisbetween a target vessel 30 and a graft vessel 32 with a plurality ofstaples 22. The spacing between the staples 22 is approximately 1 to 4mm. This spacing is similar to the spacing between sutures in aconventional sutured anastomosis. A different spacing between thestaples 22 may be used if desired. After completion of the anastomosis,the anvil arm 14 is withdrawn from the target vessel 30 between adjacentstaples 22. The withdrawal of the anvil arm 14 leaves a gap that isapproximately the same as the spacing between adjacent staples.Accordingly, substantially no blood leakage occurs at the location wherethe anvil arm has been withdrawn.

FIGS. 7 and 8 illustrate one example of a staple 22 connected to astaple holding strip 24. This staple 22 includes barbed staple ends 52extending from the front portion of the staple 22 and a C-shaped portion54 extending from a rear of the staple 22 for connecting the staple 22to the staple holding strip 24. The staple holding strip 24 includes aplurality of protrusions 56 for receiving the staples 22. The C-shapedportion 54 of each staple 22 is received around one of the protrusions56 and is secured in place at one or more locations, such as by welds 58or by a frangible linkage or connection. Alternately, the C-shapedportion 54 of each staple 22 may be secured to the staple-holding strip24 in a different way. As shown in FIG. 8, when the staple holding strip24 is advanced toward the anvil arm 14, the barbed staple ends 52 arereceived in the recesses 20 in the anvil arm 14. Contact between eachstaple end 52 and the corresponding recess 20 generates a moment thatcauses the barbed staple ends 52 to bend towards one another. At thesame time that the barbed staple ends 52 bend over, or after the bendingof the staple ends 52, the staple 22 is detached from the staple holdingstrip 24. The staple 22 may be detached from the staple holding strip 24by the action of bending the barbed staple ends 52 such that theC-shaped portion 54 of the staple 22 splays outward and breaks apartfrom the corresponding protrusion 56 on the staple holding strip 24, bybending a frangible connection between the staple holding strip and thestaples to separate the staples, or any other known separation methods,such as melting of a connection between the staple and the stapleholding strip.

FIG. 9 illustrates an alternate staple 22 a having inwardly curvedbarbed staple ends 52 a. Because the staple ends 52 a are themselvescurved, the corresponding staple bending feature or features 16 a neednot be curved to bend the ends 52 a of the staples 22 a. As shown inFIG. 9, the staple bending features 16 a on each side of the anvil arm14 a may be formed as a single longitudinal groove along the anvil arm14 a, where the staple bending feature 16 a has a substantially flatsurface. When the curved ends 52 a of the staple 22 a are received inthe groove 16 a of the anvil arm 14 a, the ends bend inward to securethe tissue with the staple. Alternately, the staple may be configureddifferently. Alternately, two or more different kinds of staples aredeployed by the staple holder 38 in order to form a single anastomosis.

Referring also to FIG. 10A, a plurality of staples 22 a are positionedon an expandable staple holding strip called an expandable backbone 66.The expandable backbone 66 includes a plurality of elements 68 which areinterconnected by one or more expanding members 70. Each of the backboneelements 68 is provided with a connecting diamond member 72 that isconnected to one of the staples 22 a. As shown in FIG. 10A, each staple22 a is connected to the corresponding diamond member 72 by a thinconnecting section 74. The expandable backbone 66 allows the spacingbetween the staples 22 a to be adjusted for the particular anastomosisto be performed. The backbone 66 allows expansion of the distancebetween staples from a distance of approximately 0.1 mm to a distance ofapproximately 1 to 4 mm, i.e., expansion of up to 40 times the originalspacing. Alternately, the backbone 66 allows a different amount ofexpansion. The expanding backbone 66 also includes two openings 76 atopposite ends which may be engaged by holding pins (not shown) on ananastomosis system or staple holder. The opening 76 allow the backbone66 to be easily expanded by relative motion of the holding pins. Theconnecting diamond members 72 are configured to collapse inwardly towardthe backbone when the staples 22 a engage the staple bending surface orsurfaces 16 a of the anvil. The collapsing of each diamond member 72forces the corresponding staple 22 a to separate from the diamond member72 at a connecting section 74. The connecting section 74 is a frangiblelinkage connecting a staple 22 a to a corresponding diamond member 72.

FIG. 10B illustrates another example of staples 22 a detachablyconnected to a backbone 66. The staples 22 a are each connected to theassociated backbone elements 68 at two connecting sections 74. Thestaples 22 a, backbone 66, and associated components are substantiallyas described above with regard to FIG. 10A.

Cutting Device

FIG. 11 shows a portion of an anvil arm 14 with a movable cutting device44. The cutting device 44 includes a base 46 and a blade 48. The base 46of the cutting device 44 is positioned in a longitudinal groove 50 inthe anvil arm 14. After the anvil arm 14 has been inserted into thetarget vessel, the cutting device 44 may be moved longitudinally alongthe anvil arm 14 to form an incision in the target vessel.

FIGS. 12, 12A, and 12B illustrate external cutting devices that areadvanced onto the anvil arm 14 after the anastomosis procedure and cutan incision in the target vessel from an exterior of the target vesselas the anvil arm 14 is withdrawn. As shown in FIG. 12, a knife 62 ispositioned on a knife arm 64 that is movable along the handle 12 of theanvil. The knife 62 is moved downward in a direction substantiallyparallel to the longitudinal axis of the handle 12 until the knife 62engages a recess 65 in the anvil arm 14. The knife 62 is therebypositioned substantially at the anastomosis site. The end of the graftvessel is then placed substantially against the wall of the targetvessel at the anastomosis site, over the knife 62 and knife arm 64. Asthe anvil arm 14 is withdrawn from the anastomosis site, the knife 62forms an incision in the target vessel. The knife 62 and knife arm 64exit the anastomosis site via the joint between the graft vessel and thetarget vessel. The withdrawal of the anvil arm 14, knife 62 and knifearm 64 leaves a gap in the wall of the target vessel that isapproximately the same as the spacing between adjacent staples tominimize or eliminate leakage through that gap. Alternately, the knife62 may be moveable relative to the handle 12 in at least one directionin addition to or instead of a direction substantially parallel to thelongitudinal axis of the handle 12. For example, the knife 62 may bemoveable in a direction substantially parallel to the wall of the targetvessel to create an arteriotomy in the target vessel at the junctionbetween the graft vessel and the target vessel.

FIGS. 12A and 12B illustrate two alternate examples of the knife 62which snap onto a corresponding engagement surface 65 of the anvil arm14 so that the knife 62 and anvil arm 14 are secured together forformation of the incision during removal of the anvil arm 14 from theanastomosis site.

FIGS. 13-16 illustrate two variations of extendable cutting devices formaking an incision in the target vessel while withdrawing the anvil arm14 from the target vessel. FIG. 13 illustrates an anvil arm 14 b havinga blade 78 connected to a flexible blade support 80. When the bladesupport 80 is pulled in the direction of the arrow A with respect to theanvil arm 14 b, the blade 78 moves from a forwardly extending positionshown in FIG. 13 to an upwardly extending position shown in FIG. 14 as aresult of flexure of the blade support 80. The blade 78 in the forwardlyextending position may be used to form a small opening in the wall ofthe target vessel through which the anvil arm 14 is inserted into thetarget vessel. After an anastomosis has been performed, or while ananastomosis is performed, the blade 78 is moved to an upwardly angled ora vertical position in which the blade 78 is used to form an incision inthe target vessel as the anvil arm 14 b is removed from the targetvessel.

FIGS. 15-16 illustrate an alternate example of an anvil arm 14 c havinga blade 84 and a blade support 86. While the anvil arm 14 c is insertedinto the target vessel and during the anastomosis procedure, the blade84 is positioned in a recess 88 in the anvil arm. The blade 84 may bemoved from the position of FIG. 15 to the extended position of FIG. 16by moving the blade support 86 in the direction of the arrow B withrespect to the anvil arm. The blade 84 is flexible and stressed, suchthat freeing the blade 84 from the recess 88 causes the blade 84 to moveto the extended position. Alternatively, the blade 84 may be extendedautomatically upon withdrawal of the anvil arm 14 when a blade tip 90catches on an interior surface of the target vessel wall duringwithdrawal of the anvil arm.

The extendable cutting devices shown in FIGS. 13-16 are merely shown asexamples of the type of cutting devices which may be used for making theincision. Once these cutting devices or blades have been extended fromthe anvil arm 14, they may be fixed to perform cutting as the anvil arm14 is removed from the target vessel or the blades may be movable alongthe anvil arm 14 to make an incision prior to removal of the anvil arm14 from the target vessel.

Anastomosis Tool

Referring to FIG. 55, another exemplary anastomosis tool 300 is shown.The anastomosis tool 300 includes a handle 302, a shaft 304 connected tothe handle 302, a cable housing 306 connected at one end to the handle302, and a tissue effector 400 connected to both the shaft 304 and thecable housing 306. The anastomosis tool 300 may be configureddifferently, if desired. For example, the cable housing 306 may beomitted, and the cable or cables (not shown) or other force transmissionmembers that would otherwise extend therethrough are instead routedthrough the shaft 304. The handle 302 and/or the tissue effector 400 maybe detachable from the shaft 304 to allow for interchangeability ofthese components. In this way, the same handle 302 may be used toperform more than one anastomosis within a single patient, where adifferent tissue effector 400 may be connected to that handle 302 foreach anastomosis. Further, the handle 302 may be constructed frommaterials that can be sterilized, such as by an autoclave, and reused.The handle 302 may assume any appropriate configuration; the shape andconfiguration of the handle 302 described herein is exemplary and notlimiting. The shaft 304 may be a rigid hollow structure such as a tubeof stainless steel, but may be shaped differently and/or fabricated froma different material. Further, the shaft 304 may be flexible at least inpart, rather than rigid. Alternately, the shaft 304 may be omittedaltogether, such that the handle 302 is connected to the tissue effector400 by one or more cables or other force transmission members that wouldotherwise have extended through the shaft 304. The handle 302 mayinclude a trigger 308 that provides for actuation of the anastomosistool 300 based solely on a single input to that trigger 308, asdescribed in greater detail below. Alternately, one or more other oradditional inputs may be utilized to actuate the anastomosis tool 300.For example, actuation of the anastomosis tool 300 may be based on aninput to one or more buttons in addition to the trigger 308.

The tissue effector 400 includes an anvil 10 and a staple holder 38. Thetissue effector 400 may be permanently fixed to the shaft 304, or may bedetachable from it such that is it decoupled from the handle 302. Thatis, tissue effectors 400 may be interchangeable. Alternately, the shaft304 is not provided, and the tissue effector 400 is directly coupled tothe handle 302. One end of the cable housing 306 may be fixed to thestaple holder 38.

The anvil 10 of the tissue effector 400 may be as described above, ormay be configured differently. The anvil 10 may be formed from anymaterial or combination of materials having a suitable stiffness. As oneexample, the anvil 10 is formed from stainless steel. As anotherexample, at least part of the lower portion of the anvil 10 is formedfrom tungsten carbine for enhanced stiffness, and the upper portion ofthe anvil 10 is formed from stainless steel. Other or additionalmaterials or combinations may be used. Advantageously, the anvil 10 alsoincludes a cutter 200 that is moveable relative to the anvil 10 formaking an incision in the wall of a target vessel. Referring to FIGS. 34and 35, a tissue stop 220 is formed into or connected to the anvil 10.The portion of the anvil 10 distal to the tissue stop 220 is configuredto penetrate the wall of a target vessel, and may be referred to as theanvil arm 14. A channel 246 is defined within the anvil arm 14, throughwhich a cutter 200 is configured to move. The cutter 200 is narrowerthan the channel 246, such that interior surfaces 202 on either side ofthe channel 246 may guide the translation of the cutter 200 relative tothe anvil arm 14. As used in this document, the term “translation” asused in regard to the cutter 200 refers to motion of the cutter 200 inthe distal or proximal direction, whether or not the cutter 200 or aportion thereof moves upward or downward during that motion. Forconvenience, the direction substantially perpendicular to thelongitudinal centerline of the anvil arm 14 toward the wall of thetarget vessel may be referred to as “upward”, and the directionsubstantially perpendicular to the longitudinal centerline of the anvilarm 14 away from the wall of the target vessel may be referred to as“downward”. However, the positioning of the anvil arm 14 in use is notlimited to an orientation in which these directions correspond toabsolute directions measured relative to the ground. Similarly, forconvenience, motion upward or downward may be referred to as “vertical”motion, and motion substantially parallel to the longitudinal centerlineof the anvil arm 14 may be referred to as “horizontal” motion.

The anvil arm 14 includes a contact surface 206. Referring also to FIG.36, in use, the contact surface 206 of the anvil arm 14 is placedsubstantially against the inner surface 203 of a target vessel 201. Thecontact surface 206 substantially defines a plane that is substantiallyparallel to the longitudinal centerline of the anvil arm 14.Alternately, the contact surface 206 is contoured and/or orienteddifferently. An upper opening 248 extends along at least a portion ofthe contact surface 206 in a direction substantially parallel to thelongitudinal centerline of the anvil arm 14, and opens into the channel246. The upper opening 248 may divide the contact surface 206 intosymmetrical or asymmetrical sections. Further, the contact surface 206may be formed by two substantially planar surfaces, by one substantiallyplanar surface and a differently-shaped surface, or by another set ofsurfaces. Additionally, the contact surface 206 may be formed by twothin edges, each edge occurring at the intersection of a wall of theupper opening 248 and an outer surface of the anvil arm 14. The upperopening 248 need not extend proximally any further than the tissue stop220. However, the upper opening 248 may extend proximal to the tissuestop 220, if desired. A first lower opening 254 and a second loweropening 268 are defined through a lower surface 256 of the anvil arm 14.The lower surface 256 of the anvil arm 14 may be substantially parallelto the contact surface 206 or may be oriented differently relative tothe contact surface 206. Alternately, the first lower opening 254 and/orthe second lower opening 268 do not extend completely through the anvilarm 14, and instead are depressions extending along at least part of abottom surface 266 of the channel 246.

Cutter

Referring also to FIGS. 37-38, the cutter 200 may be a thin, rigidmember, shaped such that it can be held within and/or moved along thechannel 246 in the anvil arm 14. The cutter 200 has a substantiallyconstant width along its entire length. Alternately, the width of thecutter 20 may vary along its length. The cutter 200 may be made ofmetal, ceramic, plastic, or other material, or from a combination ofdifferent materials. A sharp projection 208 extends upward from thecutter 200 at or near its distal end. The projection 208 issubstantially triangular, but may be shaped differently. The projection208 may be smooth or serrated, or otherwise shaped or formed. A portionof the projection 208 may be ground or otherwise honed to a sharp edgeto facilitate the motion of the projection 208 through the tissue of thewall of a target vessel, as described in greater detail below. If so,the cutter 200 is composed of a material that can be sharpenedadequately to cut tissue. Alternately, the cutter 200 may be flexible,at least in part. Further, the projection 208 may be located at adifferent position on the cutter 200 than at or near its distal end. Anadditional sharp point (not shown) may be provided at the distal end ofthe cutter 200, extending in a distal direction, in order to create aninitial puncture or incision in the wall of the target vessel. Such apoint may be as described in U.S. patent application Ser. No.10/134,081, filed Apr. 24, 2002, now U.S. Pat. No. 7,530,987, issued May12, 2009, which patent is hereby incorporated herein by reference in itsentirety.

One or more additional projections 208 may be provided, if desired. Forexample, two or more projections 208 may extend upward from the cutter200. Where multiple projections 208 are used, they may cooperate withone another to create an incision in the wall of the target vessel.Referring also to FIG. 39, a second projection 208 extends upward fromthe cutter 200 proximal to a first projection 208. The projections 208are both substantially the same triangular shape and the same size.However, the projections 208 may be shaped and sized differently. Theprojections 208 are both substantially planar, and are aligned such thatboth projections 208 lie in substantially the same plane. Alternately,at least one projection 208 is not substantially planar. Each projection208 may include at least one sharpened or beveled edge 209 oriented toengage and incise the wall of the target vessel when the cutter 200 istranslated, as described below. Referring to FIG. 40, at least twoprojections 208 extend upward from the cutter 200. The projections 208each have a barb 211 at the tip. However, the barb 211 may be omittedfrom some or all of the projections 208. Under the barb 211, a sharpenedor beveled edge 209 extends downward and proximally. The edge 209 may bestraight or curved. The upper end of the edge 209 is distal to thelower, proximal end of the corresponding barb. The edge 209 of eachprojection 208 is oriented to engage and incise the wall of the targetvessel when the cutter 200 is translated. Referring to FIG. 41, at leasttwo projections 208 extend upward from the cutter 200, at least one ofwhich has a barb 211 at its tip. The edge 209 associated with eachprojection 208 is more curved than the edge 209 shown in FIG. 40.Alternately, the edge 209 is substantially straight, or gently curved,or positioned on a portion of a larger curved segment 213 extendingdownward from and proximal to the barb 211. Referring to FIG. 42, anumber of projections 208 may be placed along a length of the cutter200. This length may be comparable to the desired length of the incisionin the wall of the target vessel. These projections 208 may besubstantially triangular as shown, or may be shaped differently. Wheremore than one projection 208 is used on the cutter 200, the projections208 need not have the same configuration. For example, projections 208such as the exemplary projections 208 shown in FIGS. 39-41 may be mixedtogether on the same cutter 200. Alternately, one or more of theprojections 208 are moveable relative to the cutter 200, such that oneor more projections 208 can be moved upward or downward relative to thecutter 200.

As another example of a configuration of the projections 208, referringto FIG. 43, the projections 208 extending upward from the cutter 200each are substantially planar, and are aligned such that not all of theprojections 208 lie in the same plane. In such a configuration, theprojections 208 may create a wider incision in the wall of the targetvessel than would be created if the projections 208 were substantiallyaligned. For example, one set of projections 208 may be alignedsubstantially in a first plane, and a second set of projections 208 maybe aligned substantially in a second plane substantially parallel to thefirst plane. The second plane and the first plane may be orienteddifferently relative to one another, if desired. As another example,none of the projections 208 lie in a common plane with one or more otherprojections 208. Referring to FIGS. 39-42, by using multipleprojections, the cutter 200 need not be translated as far to make anincision in the wall of the target vessel as it would if only a singleprojection 208 were used, as described in greater detail below.

Referring to FIGS. 115-118, another example of a cutter 200 is shown.This cutter 200 is an assembly that includes a projection 208 rotatableor otherwise movable from a stowed position in which it is substantiallycompletely within the channel 246 in the anvil arm 14 (shown in FIG.115) to an active position in which at least a portion of the projection208 extends upward from the channel 246 in the anvil arm 14 (shown inFIGS. 116-117). The projection 208 may include an edge 209 that isbeveled or sharpened, where that edge 209 may be oriented at leastpartially distally when the projection 208 is in the active position.Alternately, the edge 209 may be oriented at least partially proximallywhen the projection 208 is in the active position. The orientation ofthe edge 209 when the projection 208 is in the active position isrelated to the direction of motion of the projection 208 as it createsan incision in the target vessel 580, as is described in greater detailbelow. With reference to the active position, where the edge 209 isdefined on a distally-facing surface of the projection 208, theproximally-facing surface of the projection 208 may be blunt. Similarly,where the edge 209 is defined on a proximally-facing surface of theprojection 208, the distally-facing surface of the projection 208 may beblunt.

A member 848 is connected to the projection 208. The member 848 is atleast partially rigid. An aperture 849 is defined through the projection208. The distal end of the member 848, or a portion of the member 848near its distal end, is received into or through that aperture 849 toconnect to the projection 208. Alternately, the member 848 is connectedto the projection 208 in a different way. The member 848 extends alongthe channel 246 in the anvil arm 14. A pusher 850 also extends along thechannel 246 in the anvil arm 14. The pusher 850 is a substantially rigidbody, having a distal end that is configured to engage the projection208. The distal end of the pusher 850 may be beveled or otherwise shapedsuch that at least the upper portion of that distal end is angled orcurved proximally. The distal end of the pusher 850 is configured toremain substantially in contact with the projection 208 in both thestowed position and the active position. Alternately, the pusher 850engages the projection 208 in a different manner. The aperture 849 inthe projection 208 may be located at a position lower than thelongitudinal centerline of the pusher 850. Alternately, the aperture 849is positioned differently relative to the pusher 850.

A spring 852 may be connected to or otherwise associated with the pusher850. The spring 852 may be a leaf spring, a compression spring, or anyother suitable type of spring or biasing element. The spring 852 isconfigured to press the pusher 850 downward against the bottom surface266 of the channel 246 in the anvil arm 14 when the projection 208 is inthe stowed position. In this way, the pusher 850 is held substantiallyin place when the projection 208 is in the stowed position. The spring852 is also configured to release the pusher 850 and allow it totranslate when the cutter 200 is in the active position. Optionally, abutton 854 is configured to press the spring 852 downward and therebyhold the pusher 850 in place when the projection 208 is in the stowedposition, and is movable to a position in which it no longer presses thespring downward and thereby releases the pusher 850 when the projection208 is in the active position. The spring 852 may be connected to thebutton 854 rather than the pusher 850. A stop 856 may be connected to orformed into the channel 246 of the anvil arm 14, where that stop 856 isconfigured to engage the spring 852 or other portion of the cutter 200and arrest its motion at a particular location, as described in greaterdetail below.

As another example of biasing the cutter 200 in a particular direction,a cavity 262 may be defined within the staple holder 38 or a separatecomponent connected to the staple holder 38. A post 258 is positioned atthe upper end of the cavity 262, where the post 258 is orienteddownward. A biasing element 260 is connected at one end to the post 258.The biasing element 260 may be a coil spring, a leaf spring, a differenttype of spring, an elastomer, a wire form, or other structure ormechanism capable of exerting a biasing force. The biasing element 260is positioned within and protected by the cavity 262, where the cavity262 is used. The cavity 262 may be a cylindrical opening having adiameter substantially the same as the outer diameter of the biasingelement 260, such that the cavity 262 restricts the biasing element 260to motion substantially along the axis of the cavity 262 and thusdirects the force exerted by the biasing element 260 in a substantiallydownward direction, preventing bending or other undesirable motion ofthe biasing element 260. The end of the biasing element 260 that is notconnected to the post 258 contacts the cutter 200. As an example, thebiasing element 260 may be a compression spring that is compressedbetween the post 258 and the cutter 200, resulting in a force on thecutter 200 that biases the cutter 200 downward. The cutter 200 isslidable relative to the biasing element 260, such that the biasingelement 260 exerts a downward force on the cutter 200 at differentlocations along its upper surface 252 as the cutter 200 translates.Thus, at least the distal end of the cutter 200 is biased downwardthroughout its translation along the anvil 10. The entire cutter 200 maybe biased downward, if desired. Alternately, the post 258 is omitted,and the biasing element 260 is fixed to an upper surface of the cavity260. Alternately, the biasing element 260 is omitted, and the cutter 200is biased downward in another way. For example, the cutter 200 may beconstructed from an elastic or superelastic material that is formed insuch a way as to produce a downward bias.

Referring to FIGS. 119-122, another embodiment of a cutter 200 is shown.In this embodiment, the cutter 200 is an assembly that includes aprojection 208 rotatable or otherwise movable from a stowed position inwhich it is substantially completely within the channel 246 in the anvilarm 14 (shown in FIG. 119) to an active position in which at least aportion of the projection 208 extends upward from the channel 246 in theanvil arm 14 (shown in FIGS. 120-121). The projection 208 may include anedge 209 that is beveled or sharpened, where that edge 209 may beoriented at least partially distally when the projection 208 is in theactive position. Alternately, the edge 209 may be oriented at leastpartially proximally when the projection 208 is in the active position.The orientation of the edge 209 when the projection 208 is in the activeposition is related to the direction of motion of the projection 208 asit creates an incision in the target vessel 580, as is described ingreater detail below. With reference to the active position, where theedge 209 is defined on a distally-facing surface of the projection 208,the proximally-facing surface of the projection 208 may be blunt.Similarly, where the edge 209 is defined on a proximally-facing surfaceof the projection 208, the distally-facing surface of the projection 208may be blunt. The projection 208 includes a lobe 858 defined therein orconnected thereto, where the lobe 858 is located on the lower portion ofthe projection 208 with reference to the position of the projection 208in the stowed position. The lobe 858 may be curved or rounded. A slot860 is located in the bottom surface 266 of the channel 246 in the anvilarm 14. The slot 860 may extend completely through that bottom surface266, or may simply be a depression or other feature defined in thatbottom surface 266. When the cutter 200 is in the stowed position, atleast part of the lobe 858 extends into that slot 860. An aperture 849is defined in the projection 208. A clip 862 is connected to theprojection 208 through the aperture 849. The clip 862 may be U-shaped,or shaped in any other suitable manner. The clip 862 may be configuredto slide along at least one track 864 defined in or connected to atleast one interior surfaces 202 of the channel 264.

A pusher 850 also extends along the channel 246 in the anvil arm 14. Thepusher 850 is a substantially rigid body, having a distal end that isconfigured to engage the projection 208. The distal end of the pusher850 may be beveled or otherwise shaped such that at least the lowerportion of that distal end is angled or curved proximally. The distalend of the pusher 850 is configured to remain substantially in contactwith the projection 208 in both the stowed position and the activeposition. Alternately, the pusher 850 engages the projection in adifferent manner. The aperture 849 in the projection 208 may be locatedat a position lower than the longitudinal centerline of the pusher 850.Alternately, the aperture 849 is positioned differently relative to thepusher 850. As described above, the pusher 850 may be substantiallyrestrained when the projection 208 is in the stowed position andsubstantially freed when the projection 208 is in the active position.

Referring to FIGS. 125-128, another example of a cutter 200 is shown.The cutter 200 is an assembly that includes a projection 208 rotatableor otherwise movable from a stowed position in which it is substantiallycompletely within the channel 246 in the anvil arm 14 (shown in FIG.125) to an active position in which at least a portion of the projection208 extends upward from the channel 246 in the anvil arm 14 (shown inFIGS. 126-127). At least one edge 209 of the projection 208 may bebeveled or otherwise sharpened. A member 848 is connected to theprojection 208. The member 848 is a cable or any other appropriatestructure or mechanism. For example, the member 848 may be at leastpartially rigid. An aperture 849 is defined through the projection 208.The distal end of the member 848, or a portion of the member 848 nearits distal end, is received into or through that aperture 849 to connectto the projection 208. Alternately, the member 848 is connected to theprojection 208 in a different way. The member 848 extends along thechannel 246 in the anvil arm 14.

The projection 208 includes a lobe 858 defined therein or connectedthereto, where the lobe 858 is located on the lower portion of theprojection 208 with reference to the position of the projection 208 inthe stowed position. The lobe 858 may be curved or rounded. A notch 859may be located between the lobe 858 and the remainder of the projection208. The notch 859 may be curved, rounded, angled or otherwiseconfigured. A slot 860 is located in the bottom surface 266 of thechannel 246 in the anvil arm 14. The slot 860 may extend completelythrough that bottom surface 266, or may simply be a depression or otherfeature defined in that bottom surface 266. When the cutter 200 is inthe withdrawal position, at least part of the lobe 858 extends into thatslot 860. The projection 208 includes two sharp edges 209.

A centerpiece 868 may be secured within the channel 246. For example,the centerpiece 868 may be connected to one or more pins 870 that areconnected to or formed into the anvil arm 14. Alternately, thecenterpiece 868 is positioned at least partially above the channel 246,and/or may extend laterally from at least one edge of the channel 246,as shown in FIG. 143. The centerpiece 868 includes a slot 872 in itsupper surface to allow the projection 208 to extend therethrough, andincludes a longitudinally-extending free space 874 that allows theprojection 208 to travel longitudinally therethrough. A receiving space876 is defined at or near the distal end of the centerpiece 868,oriented downward. The receiving space 876 is located distal to a firstcam surface 878, which is positioned lower than the uppermost part ofthe receiving space 876. Alternately, the centerpiece 868 is not used.

Referring back to FIGS. 34-35, an interior surface 202 is located oneach side of the channel 246. Each interior surface 202 may besubstantially planar, curved, or may be shaped differently. Further,each interior surface 202 may be oriented at an angle to vertical orsubstantially vertical. The interior surfaces 202 may be formed suchthat the channel 246 is substantially bilaterally symmetrical, or may beformed to result in a channel 246 that is not bilaterally symmetrical.The interior surfaces 202 of the channel 246 within the anvil arm 14 mayinclude raised features 204 that correspond to depressed staple bendingfeatures (not shown) on the outer surface of the anvil arm 14. That is,if the staple bending features are stamped into the anvil arm 14, orformed in another way that causes deformation of the anvil arm 14, thedepressed staple bending features result in corresponding raisedfeatures 204 on the interior surface 202 of the channel 246. The raisedfeatures 204 do not interfere with the motion of the cutter 200 throughthe channel 246. Alternately, the raised features 204 are not present onthe interior surface 202 of the channel 246.

Shield

Optionally, referring to FIGS. 93-94, a shield 290 may be connected tothe anvil arm 14, at or near the proximal end of the anvil arm 14. Forexample, the shield 290 may be connected to the anvil arm 14 inproximity to the tissue stop 220. Alternately, the shield 290 may beconnected to a different location on the anvil arm 14, or to a portionof the anvil 10 other than the anvil arm 14. Alternately, the junctionbetween the shield 290 and the anvil arm 14 performs the function of thetissue stop 220, and a separate tissue stop 220 is not provided. Theshield 290 may be connected to or formed into the anvil arm 14 in anyappropriate manner. As one example, the shield 290 may be pressure-fitto the anvil arm 14 at or near the tissue stop 220. Alternately, theshield 290 may be connected to the anvil arm 14 by welding, by adhesive,or by any other appropriate structure, mechanism, or method. Theproximal end of the shield 290 is connected to the anvil arm 14, and thedistal end of the shield 290 is free. Alternately, the shield 290 isconnected to the anvil arm 14 in a different orientation. The shield 290may be connected to the anvil arm 14 such that the free end of theshield 290 is biased upward relative to the anvil arm 14. However, thefree end of the shield 290 need not be biased upward, or in any otherdirection, relative to the anvil arm 14. Alternately, the shield 290 maybe biased downward relative to the anvil arm 14.

The shield 290 is configured to be positioned at least partiallyadjacent to the outer surface of the target vessel during theanastomosis procedure, as described in greater detail below. As oneexample of such a configuration, a proximal element 292 of the shield290 is substantially straight, such that it substantially can contactthe outer surface of the target vessel during the anastomosis procedure.A raised element 293 of the shield 290 at or near its distal end israised relative to the proximal element 292 of the shield 290. A firstramp element 294 of the shield 290 connects the proximal element 292 ofthe shield 290 to the raised element 293 of the shield 290. A secondramp element 295 may extend distally and downward from the raisedelement 293 of the shield 290. At least a portion of the second rampelement 295, such as its distal end, is configured to contact the outersurface of the target vessel. This contact provides a limit to themotion of the shield 290 relative to the anvil arm 14 and causes theraised element 293 to be spaced apart from the outer surface of thetarget vessel. The second ramp element 295, or distal end of the raisedelement 293 if the second ramp element 295 is not used, is blunt toprevent damage to the outer surface of the target vessel upon contacttherewith. Alternately, the shield 290 may be configured and/or shapeddifferently.

Optionally, an aperture 296 extends substantially longitudinally alongat least a portion of the shield 290. The aperture 296 has a closedperimeter, or alternately may be open ended. The aperture 296 issubstantially aligned with the channel 246 in the anvil arm 14. Thuswhen the projection 208 of the cutter 200 extends above the contactsurface 236 of the anvil arm 14, at least a portion of the aperture 296receives at least part of the projection 208 and allows it to slidefreely. The aperture 296 extends along the shield 290 a sufficientdistance to allow the projection 208 to slide freely throughout itsentire travel, as described in greater detail below. A tip element 297may be located at or near the distal end of the shield 290, orientedsubstantially transversely and closing the distal end of the aperture296. The tip element 297 may be oriented differently, if desired. Theaperture 296 need not be provided, such as where the shield 290 isconfigured to remain above and out of contact with the projection 208throughout its path of motion. The shield 290 may be composed ofpolyethylene such that it is both flexible and durable. However, anyother suitable material may be utilized if desired.

Alternately, referring to FIG. 106, the shield 290 may be connected tothe staple holder 38. As one example, the shield 290 includes a snapfeature 898 that connects to an aperture 900 in the staple holder 38.The snap feature 898 is compressible for insertion into the aperture900, and expands after it is released. Friction between the snap feature898 and the aperture 900, and/or interference between portions of thesnap feature 898 above the aperture 900 and the structure in proximityto the aperture 900, hold the shield 290 in place. This snap feature 898is utilized for ease of assembly; the shield 290 is connected to thestaple holder 38 throughout the anastomosis procedure. Alternately, theshield 290 is connected to the staple holder 38 in a different manner.Alternately, the shield 290 is detachable from the staple holder 38. Theshield 290 extends upward and proximally from its point of connection tothe staple holder 38, then curves to extend downward and distally; thisportion of the shield 290 may be referred to as the hinge 902. Theremainder of the shield 290 extends substantially distally from thehinge 902 substantially as described above. The shield 290 may includean aperture 296 therein and/or be otherwise configured substantially asdescribed above. Further, the shield 290 is utilized, and removed fromthe anastomosis site, in substantially the same manner as theconfiguration of shields 290 described above. By connecting the shield290 to the staple holder 38 rather than the anvil 10, preparation of thegraft vessel 404 and/or manufacture of the tissue effector 400 may besimplified. At least the hinge 902 of the shield 290 is composed ofpolyethylene or other flexible material. In this way, the hinge 902 canflex to allow the tissue effector 400 to move from the open position tothe closed position.

Referring also to FIGS. 144-145, another example of a shield 290connected to the staple holder 38 is shown. In this example, the shield290 is connected to a location at or near the distal end of the stapleholder 38. The shield 290 is connected to the staple holder 38 by ahinge 966. The hinge 966 may be oriented in a substantially transversedirection. Where the hinge 966 is used, the shield 290 may be flexibleor rigid. Alternately, the shield 290 may be flexible, and fixed to thestaple holder 38. Alternately, the shield 290 is connected to the stapleholder 38 in any other suitable manner.

Tissue Effector

The tissue effector 400 may include one or more other features.Optionally, the anvil 10 and the staple holder 38 are configured to snaptogether when the tissue effector 400 moves to the closed position. Anysuitable mechanism or structure may be used to hold the tissue effector400 in the closed position. As an example, a first tab 904 extends fromthe tissue stop 220 or other portion of the anvil 10, and a second tab906 extends from a corresponding location on the staple holder 38. Asthe tissue effector 400 moves to a closed position, at least one of thetabs 904, 906 flexes to accommodate the other tab 904, 906, until thefirst tab 904 is located above the second tab 906. Once the tissueeffector 400 has been closed, the tabs 904, 906 are configured such thatthe tissue effector 400 cannot easily re-open. In this manner, thetissue effector 400 is positively held in the closed position.

Optionally, a safety feature 210 may be connected to the underside ofthe anvil 10. The safety feature 210 is biased toward the anvil 10 andthe cutter 200. The safety feature 210 may be biased into the channel246 within the anvil 10. Alternately, the safety feature 210 isconnected to a different location, such as the underside of the anvilarm 14. The safety feature 210 may be flexible or rigid. The safetyfeature 210 includes a tip 212 that is oriented substantially transverseto the longitudinal centerline of the cutter 200. Alternately, the tip212 may be oriented in a different direction. If the safety feature 210is provided, the cutter 200 may include a safety recess 214 defined init, corresponding to the tip 212 of the safety feature 210. The tip 212is shaped and sized such that it can engage the safety recess 214. Thetip 212 may be a bar or rod oriented substantially transverse to thedirection of translation of the cutter 200, or may be shaped or orienteddifferently.

In FIG. 34, the staple holder 38 has not yet been moved into position toperform anastomosis. In this position, if the safety feature 210 isprovided, the tip 212 of the safety feature 210 is biased upward toengage the safety recess 214. The engagement between the safety recess214 and the tip 212 of the safety feature 210 substantially preventstranslation of the cutter 200 within the channel 246. Thus, the cutter200 and the projection 208 are prevented from deploying until the stapleholder 38 has been moved into the appropriate position relative to theanvil arm 14, and inadvertent actuation of the cutter 200 is prevented.

The cutter 200 may include an engagement member 216 extending upwardfrom a location at or near its proximal end. The engagement member 216instead may extend downward from the cutter 200 or to the side of thecutter 200. Further, the engagement member 216 may be positioned at alocation other than at or near the proximal end of the cutter 200. Theengagement member 216 is configured to engage at least a portion of acorresponding receiver 218 in the staple holder 38. Thus, afterengagement between the engagement member 216 and the receiver 218,translation of the receiver 218 results in translation of the cutter200. The receiver 218 is a structure that is at least partially open onits underside and that includes at least one surface 219 configured toengage the engagement member 216. As shown in FIG. 34, the surface 219is a partially-curved surface shaped to receive the curved upper end ofthe engagement member 216. However, the receiver 218 may be a flatvertical surface, a curved surface, a structure such as an inverted cupthat is open on its underside and that has a wall or walls encirclingthe engagement member 216, or any other structure or mechanism capableof engaging the engagement member 216 and urging it distally. Referringalso to FIGS. 58 and 68-69, the receiver 218 may be defined in a sled482, which is described in greater detail below.

Optionally, an anvil insert 222 is fixed to the anvil 10. As oneexample, the anvil 10 is wider proximal to the anvil arm 14, open at itstop with a space therein. The anvil insert 222 can be inserted into theanvil 10 through the open top of the anvil 10, such that the anvilinsert 222 is partially or completely positioned within the anvil 10.However, the anvil insert 222 may be connected to the anvil 10 inanother way. Alternately, the anvil insert 222 is connected to andcapable of motion relative to the anvil 10. Further, the anvil insert222 instead may be connected to the proximal end of the anvil arm 14, oranother location on the anvil arm 14. A cavity 228 is defined within theanvil insert 222. An aperture 230 is defined through the distal end ofthe anvil insert 222 into the cavity 228, connecting the channel 246 inthe anvil arm 14 and anvil 10 to the cavity 228. The cutter 200 extendsthrough the aperture 230, such that the distal end of the cutter 200 ispositioned within the channel 246 and the proximal end of the cutter 200is positioned within the cavity 228.

A cutter stop 236 may be formed into or connected to the anvil insert222, or formed into or connected to the anvil 10 itself or anotherstructure or mechanism. The cutter stop 236 may engage the proximal endof the cutter 200 if the cutter 200 is moved proximally to a definedposition within the cavity 228, thereby restricting its proximaltranslation.

Referring also to FIG. 56, the anvil 10 may include one or moreattachment features 270. The attachment features 270 provide a locationfor attachment of one or more cables or other force transmissionstructures or mechanisms. As one example, the attachment features 270may be one or more passages 270 through the cutter stop 236. The cutterstop 236 may include two or more spaced-apart members. If so, theattachment features 270 may be substantially aligned with one another,or offset from one another. However, the cutter stop 236 may be a singlemember, if desired. As another example, one or more of the attachmentfeatures 270 are separate from the cutter stop 236, and are positionedat a different location on the anvil 10. As another example, one or moreof the attachment features 270 may extend in a direction from the anvil10 that is other than upward.

The configuration of the attachment features 270 is related to theconfiguration of the cable or other force transmission structure ormechanism attached to it, such that the connection between them issecure. As one example, the cutter stop 236 includes two spaced-apartmembers, and the attachment features 270 are passages through the upperportion of each member of the cutter stop 236. Two separate cables areconnected to the attachment features 270. The end of each cable ispassed through one of the attachment features 270, after which it iswelded, connected with adhesive, clamped, tied or otherwise secured tothe cutter stop 236. Alternately, a single first cable is passed througheach of the attachment features 270, such that the free ends of thefirst cable are spaced apart from the attachment features 270. In thisway, no additional steps are needed to secure the first cable to theattachment features 270. However, the cable may be welded, connectedwith adhesive, clamped, tied or otherwise secured to the cutter stop236, if desired. Alternately, the force transmission member or membersmay be connected to the anvil 10 in a different manner and/or location.

Referring also to FIG. 44, the anvil 10 extends proximally to a pivotpoint such as a pin 226. The pivot point may be any other structure ormechanism that allows the anvil 10 to rotate about it. For example, thepivot point may be a four-bar linkage or other mechanism rather than thepin 226. By using a four-bar linkage or other mechanism, the stapleholder 38 and the anvil 10 may be movable relative to one another in asimple manner such as rotation, or in a more complex manner.Alternately, the anvil insert 222 extends to the pin 226 instead of orin addition to the anvil 10. The pin 226 pivotally connects the stapleholder 38 to the anvil 10. The pin 226 may be formed into or otherwisefixed to the staple holder 38 or anvil 10, if desired. The anvil 10and/or anvil insert 222 may extend still further proximally from the pin226. As one example, the anvil 10 extends proximally to the pin 226. Theanvil insert 222 also extends proximally to the pin 226, andadditionally extends as far as or further proximally to the proximal endof the anvil 10.

The staple holder 38 and the anvil 10 may be connected to one another inany other suitable manner and/or in any suitable location. As oneexample, the staple holder 38 and the anvil 10 may be connected to oneanother at the junction between the tissue effector 400 and the shaft304. The staple holder 38 and/or anvil 10 may be movable toward theother. Alternately, the staple holder 38 is substantially fixed relativeto the anvil 10. If so, the tissue effector 400 is substantially in theclosed position throughout the anastomosis procedure. Fabrication and/oroperation of the anastomosis tool 300 may be simplified if the tissueeffector 400 remains in substantially the same position throughout theanastomosis procedure.

Referring also to FIG. 57, a proximal portion of the anvil insert 222may be bent upward relative to a distal portion of the anvil insert 222.The proximal portion of the anvil insert 222 may be referred to as thespine 272. The spine 272 need not be bent upward relative to theproximal portion of the anvil insert 222, and instead may be bentdownward or oriented substantially parallel to the proximal portion ofthe anvil insert 222. Alternately, the spine 272 is a separate structureor mechanism that is connected to the anvil insert 222. A post 274 maybe defined in or connected to the spine 272. The post 274 may becylindrical, or may be shaped differently. One end of a spring 276 isconnected to the post 274. The spring 276 is a coil spring, but may be adifferent type of spring if desired. The other end of the spring 276 isconnected to the staple holder 38, such as to an attachment member 275defined in or connected to the staple holder 38. The attachment member275 may be cylindrical, or may be shaped differently. The spring 276 maybe connected to the post 274 and/or to the attachment member 275 byhooking an end of the spring 276 to at least one of the post 274 and theattachment member 275, by welding, by adhesive, or by any otherappropriate structure, mechanism or method. The spring 276 may beconnected to the staple holder 38 and/or the spine 272 in a differentway, if desired. The spring 276 is sized and configured to be intension, so as to bias the tissue effector 400 to an open position. Thatis, the spring 276 presses the staple holder 38 about the pin 226,toward the spine 272 of the anvil insert 222. Alternately, any othersuitable structure, mechanism or method may be used to bias the tissueeffector 400 to the open position. Alternately, the tissue effector 400is not biased to the open position.

Optionally, one or more buttons 278 are connected to the spine 272. Thewing or buttons 278 may be spaced apart from the spine 272 and connectedto it by one or more connection members 280. The buttons 278 each may besized and shaped for contact with a user's finger. For example, twobuttons 278 may be sized and shaped such that a user may convenientlypress one with a thumb and the other with a forefinger. The preciseshape and size of the buttons 278 is not critical to the invention.Optionally, at least one button 278 is connected to a cog 282 that inturn connects to the shaft 304 of the anastomosis tool 300, as describedin greater detail below. The cog 282 includes one or more teeth 284.Advantageously, the cog 282 is substantially circular, and the teeth 284extend substantially radially outward from it.

Graft Vessel Handling Features

Referring to FIG. 58, the underside of the staple holder 38 is seen. Thestaple holder 38 includes two arms 402, where those arms 402 are spacedapart from one another along at least part of their length, and/or atleast at one end. More or fewer arms 402 may be provided. The arms 402extend distally from the remainder of the staple holder 38. However, thearms 402 may be positioned differently, if desired. The arms 402 aregenerally linear in configuration, and the longitudinal centerlines ofthe arms 402 are substantially parallel to one another. However, thearms 402 may be shaped differently and/or oriented differently relativeto one another. One or more of the arms 402 may be angled relative to ahorizontal plane; for example, to facilitate connecting the flaps of thegraft vessel to the wall of the target vessel. Referring also to FIG.59, the arms 402 are spaced apart from one another along at least partof their length and/or at least at one end to allow a graft vessel 404to be placed between them, and to allow the tissue effector 400 to befreed from the completed anastomosis. The arms 402 may be substantiallyfixed relative to one another. Alternately, at least one arm 402 may bemovable relative to the other arm 402.

The underside of each arm 402 may include a flap receiving surface 406.Each flap receiving surface 406 is substantially flat across at least aportion of its area. Each flap 408 at the end of the graft vessel 404 isplaced onto a corresponding flap receiving surface 406, and the mainbody of the graft vessel 404 extends between the arms 402 of the stapleholder 38. Advantageously, each flap 408 is substantially flat againstthe corresponding flap receiving surface 406. One or more of the flapreceiving surfaces 406 may include a ridged region 413 that hasindividual ridges 416 spaced apart from one another. The individualridges 416 may be parallel to one another, or oriented differently. Theridges 416 extend away from the flap receiving surface 406. As oneexample, each flap receiving surface 406 includes a ridged region 413 inproximity to its inner edge. As used in this document in the context ofthe staple holder 38, the term “inner” refers to proximity to the spacebetween the arms 402, and the term “outer” refers to distance from thespace between the arms 402.

Advantageously, two flaps 408 are present at the end of the graft vessel404. These flaps 408 may be created in any appropriate manner, such asby incising the end of the graft vessel 404 with a scalpel. However, theend of the graft vessel 404 may have more than two flaps 408. Further,the end of the graft vessel 404 may have a single flap 408. That is, asingle incision may be made at the end of the graft vessel 404,substantially parallel to its centerline. As a result, a single flap 408is created that extends substantially continuously around thecircumference of the end of the graft vessel 404, where the oppositeends of the flap 408 are adjacent to the incision.

Optionally, one or more spikes 410 may extend outward from at least oneof the flap receiving surfaces 406. As at least one of the flaps 408 isplaced onto the corresponding flap receiving surface 406, one or more ofthe spikes 410 penetrate that flap 408 partially or completely, therebyassisting in holding the flap 408 in place against the flap receivingsurface 406. Alternately, no flaps are created at the end of the graftvessel 404. Rather, an end of the graft vessel 404 is simply evertedonto the flap receiving surfaces 406, spikes 410 and/or other part ofthe staple holder 38. Where the end of the graft vessel 404 is everted,the anastomosis procedure is performed in substantially the same manneras if one or more flaps 408 were utilized.

Graft Vessel Handling Features—Graft Clip

A graft clip 412 is connected to each arm 402. Each graft clip 412 maybe configured to rotate relative to the corresponding arm 402. As oneexample, each graft clip 412 is pivotally connected to the correspondingarm 402 at or near the outer edge 414 of that arm 402. Alternately, atleast one graft clip 412 is movable relative to the corresponding arm402 in a different way, such as by sliding. Alternately, at least onegraft clip 412 is initially a separate component from the arm 402, andis connectable to the corresponding arm 402. Each graft clip 412 ismoveable between an open position and a closed position relative to thecorresponding arm 402. The graft clip 412 is positioned relative to theflap receiving surface 406 on the corresponding arm 402 such that, inthe closed position, the graft clip 412 is configured to engage a flap408 of the graft vessel 404. The graft clip 412 may engage substantiallyall of the flap 408, or less than all of the flap 408. Optionally, thegraft clip 412 may include ridges 416 corresponding to ridges 416extending from the flap receiving surface 406.

Referring to FIG. 140, at least one graft clip 412 may be connected tothe staple holder 38 at a location at or near the proximal end of thestaple holder 38, such as in proximity to the proximal end of acorresponding arm 402 of the staple holder 38. The graft clips 412 maybe connected to the staple holder 38 in any suitable manner. Forexample, at least one graft clip 412 may be pivotally connected to thestaple holder 38 in such a way that the axis of rotation of the graftclip 412 is substantially perpendicular to the longitudinal axis of thestaple holder 38. Alternately, at least one graft clip 412 has an axisof rotation oriented in a different direction. The graft clips 412 areseparate and independent from one another. Alternately, the graft clips412 are connected to one another. For example, the graft clips 412 mayboth be part of a single generally U-shaped assembly, with the base ofthat U-shaped assembly positioned at or near the proximal end of thestaple holder 38.

Referring also to FIG. 58, alternately, the spikes 410 alone hold atleast one flap 408 onto the corresponding flap receiving surface 406,and one or more graft clips 412 are not used. The spikes 410 areoriented at an angle that facilitates the opening of the tissue effector400 after the flaps 408 are connected to the target vessel. Where thespikes 410 alone hold the flaps 408, the vein knives 432 that aredescribed below may be omitted, because the staple holder 38 isdisengaged from the flaps 408 simply by removal of the spikes 410 fromthe flaps 408. Thus, by eliminating the graft clips 412, construction ofthe tissue effector 400 may be simplified. Alternately, a structure ormechanism other than or in addition to the spikes 410 may be used tohold the flaps 408 onto the corresponding flap receiving surfaces 406.

Each graft clip 412 is locked or otherwise held in the closed positionto securely hold the flap 408 between itself and the corresponding flapreceiving surface 406. The pressure between the graft clip 412 and theflap receiving surface 406, alone or in conjunction with ridges 416 onthe graft clip 412 and the flap receiving surface 406 and/or spikes 410extending upward from the flap receiving surface, holds the flap 408firmly in place. The spikes 410, if used, may engage the graft clip 412when it is in the closed position. The ridges 416 on the graft clip 412and the flap receiving surface 406, if used, engage opposite sides of atleast one flap 408, thereby gripping the flap 408 firmly and resistingmotion of the flap 408 in a direction substantially perpendicular to theorientation of the ridges 416. However, each graft clip 412 may beshaped or configured in any manner that allows it to participate inholding the corresponding flap 408 to the corresponding flap receivingsurface 406.

The graft clip 412 may be locked or otherwise held in the closedposition with any appropriate mechanism, structure or method. As oneexample, the graft clip 412 uses a cam lock to hold itself in the closedposition. Referring also to FIG. 59A, the graft clip 412 is in an openposition. In the open position, the graft clip 412 is positioned toreceive a flap 408 of the graft vessel 404 between it and the flapreceiving surface 406. The graft clip 412 is rotatable about an axle 418that is spaced apart from a wall 420 defined on an arm 402 of the stapleholder 38. The wall 420 may be perpendicular or otherwise angled to theflap receiving surface 406. The axle 418 is connected to the arm 402,and is substantially fixed relative to the wall 420. Alternately, theaxle 418 is movable relative to the wall 420. The axle 418 extendssubstantially longitudinally, but may be angled relative to thelongitudinal direction. Alternately, the axle 418 may be substantiallytransverse to the longitudinal direction, or may be oriented in adifferent manner relative to the staple holder 38. The arm 402 alsoincludes an overhang 586 that extends outward and downward from the mainportion of the arm 402. Alternately, the overhang 586 extends in adifferent direction. The overhang 586 may extend laterally outward atleast as far as the longitudinal centerline of the axle 418, but neednot do so.

The graft clip 412 includes a lobe 422 in proximity to the axle 418,where the lobe 422 has a non-circular cross section. The lobe 422 has avariable thickness, where thickness is defined as the distance betweenthe surface of the axle 418 and the surface of the lobe 422. The lobe422 includes a first portion 588 that has a relatively small thickness.When the graft clip 412 is in the open position, the first portion 588is substantially adjacent to the overhang 586. The thickness of thefirst portion 588 of the lobe 422 is substantially equal to the distancebetween the axle 418 and the overhang 586. Alternately, the firstportion 588 of the lobe 422 may have a different thickness. Movingcounterclockwise along the lobe 422, its thickness increases, thendecreases rapidly to form a step 590, which may be substantially alignedwith the centerline of the axle 418. Continuing to move counterclockwisealong the lobe 422, its thickness once again increases. The graft clip412 may be a mirror image of the clip 412 shown in FIG. 59A, such thatthe thickness of the lobe 422 relative to the angular position thereonis reversed from the description above. Similarly, if the graft clip 412is viewed from the opposite direction, the thickness of the lobe 422will be reversed from the description above. The operation of the graftclip 412 is the same.

In the open position, which is the initial position of the graft clip412, the first portion 588 of the lobe 422 is adjacent to the overhang586. This first portion 588 may be substantially as thick as thedistance between the axle 418 and the overhang 586. The portion of thelobe 422 adjacent to and immediately clockwise from the step 590 may bein contact with or in proximity to the wall 420. The graft clip 412 isrotated about the axle 418 from the open position to the closed positionin a clockwise direction by the user or by a mechanism associated withthe tissue effector 400. As this rotation begins, increasingly-thickportions of the lobe 422 move between the axle 418 and the overhang 586.As a result, the overhang 586, axle 418, and/or lobe 422 may flex toaccommodate the increased amount of thickness of the lobe 422 betweenthe axle 418 and the overhang 586. Further, this increase in thicknessbetween the axle 418 and the overhand 586 may provide at least someresistance to the motion of the graft clip 412.

Referring also to FIG. 60, as the rotation of the graft clip 412continues, the step 590 encounters the overhang 586, then moves past theoverhang 586. As a result, the thickness of the lobe 422 between theoverhang 586 and the axle 418 decreases abruptly. The stiffness of theoverhang 586 is such that the overhang 586 can flex enough to allow thegraft clip 412 to rotate past the step 590. Rotation of the graft clip412 may stop at or shortly after the motion of the step 590 past theoverhang 586, such that the graft clip 412 stops at the closed positionshown in FIG. 59C. Motion of the graft clip 412 in the counterclockwisedirection would cause the step 590 to encounter the end of the overhang586, stopping the rotation of the graft clip 412. Thus, the step 590acts to hold the graft clip 412 in the closed position.

Alternately, a structure or mechanism other than a cam lock may be usedto hold the graft clip 412 in a closed position. As one example, atleast one elastic band (not shown) may be used to hold the graft clip412 against the staple holder 38. Each elastic band may be fixed toeither the graft clip 412 or the staple holder 38. As another example,the graft clip 412 and the corresponding arm 402 may each includecorresponding magnets (not shown), such that magnetic force holds thegraft clip 412 in contact with the arm 402 in the closed position.

As another example, referring to FIG. 60, a snap arm 606 may be used tohold the graft clip 412 in a closed position. The snap arm 606 isconnected at one end to the corresponding arm 402. This connection maybe a hinge, or may be any other connection that allows the snap arm 606to move between an open position, in which the graft clip 412 may beopened, and a closed position, in which the graft clip 412 is heldclosed. The connection between the proximal end of the snap arm 606 andthe arm 402 is made proximal to the flap receiving surface 406.Alternately, the connection between the snap arm 606 and the stapleholder 38 is made at a different location. Alternately, a different partof the snap arm 606 than its proximal end is connected to the arm 402.

The distal end of the snap arm 606 includes a catch 608 that is shapedto engage the distal end of the corresponding arm 402. For example, thecatch 608 may be curved such that a lobe 610 of the catch 608 isproximal to the distal end of the arm 402 when the snap arm 606 is inthe closed position, thereby holding the snap arm 606, and the graftclip 412, in place. The catch 608 is at least partially flexible suchthat the catch 608 can be snapped down onto the distal end of thecorresponding arm, thereby holding the snap arm 606 in the closedposition. The catch 608 may be configured differently, if desired. Whenthe snap arm 606 is in the closed position, at least a portion of thegraft clip 412 is positioned between the snap arm 606 and thecorresponding arm 402. Thus, in the closed position, the snap arm 606presses the graft clip 412 against the arm 402, holding it in place. Asa result, the graft clip 412 holds the corresponding flap 408 againstthe flap receiving surface 406.

Alternately, a separate snap arm 606 is not used, and the graft clip 412itself includes a catch 608 that engages the corresponding arm 402 ofthe tissue effector 400. Alternately, the snap arm 606, or the graftclip 412 that includes a catch 608, is oriented differently, such asdescribed above with regard to FIGS. 59A-59B.

Referring also to FIG. 61, in the closed position, each graft clip 412is configured to press a flap 408 of the target vessel against thecorresponding flap receiving surface 406. The flap 408 is not shown forclarity. In the closed position, the graft clip 412 and the flapreceiving surface 406 are substantially fixed relative to one another.The graft clip 412 and the corresponding flap receiving surface 406 maybe configured such that a portion of each would contact the other in theclosed position, absent the flap 408. Thus, where the flap 408 ispresent, the graft clip 412 compresses the flap 408 against the flapreceiving surface 406. Additionally, the graft clip 412 may include anoverhang 424, which extends along at least a portion of the edge of thegraft clip 412. The overhang 424 may be substantially parallel to and inproximity to the corresponding inner edge 411 of the arm 402 in theclosed position. Alternately, the overhang 424 may be configureddifferently relative to the arm 402. The overhang 402 may bend the flap408 and/or press, pinch or otherwise hold it against the correspondingedge of the arm 402.

As another example, referring to FIG. 140, at least one graft clip 412includes a clamp 952 extending from it. The clamp 952 is configured toexert a force on the staple holder 38 and/or the corresponding arm 402when the graft clip 412 is in the secure position. For example, theclamp 452 may be a tab extending from the graft clip 412 generallytoward the staple holder 38. The clamp 452 is shaped such that its freeend is laterally spaced inward from the intersection between the clamp452 and the graft clip 452. The free end of the clamp 452 is spacedinward far enough such that, as the graft clip 412 moves to the secureposition, the clamp 452 can be received onto the corresponding arm 402or other part of the staple holder 38. As the graft clip 412 continuesto move to the secure position, the clamp 452 contacts a correspondingarm 402 or other part or feature of the staple holder 38 and exerts aforce such as in the lateral direction against that corresponding arm402 or other part of the staple holder 38. The clamp 452 may exert sucha force as a result of its configuration, where the shape of the clamp452 causes friction or interference with the corresponding arm 402 orother part or feature of the staple holder 38. Alternately, at least onegraft clip 412 is held in the secure position in a different oradditional manner.

Graft Vessel Handling Features—Vein Knife

Still referring to FIG. 61, optionally a first channel 426 may bedefined in the graft clip 412, and a corresponding second channel 428may be defined in the corresponding arm 402. The first channel 426 andthe second channel 428 are substantially linear and substantiallyaligned with one another. Alternately, the first channel 426 and thesecond channel 428 are configured differently, aligned differently withrespect to one another and/or have a different cross-section. Eachchannel 426, 428 is open along one side, at least in part. The firstchannel 426 and the second channel 428 are oriented and aligned relativeto one another such that the openings in the channels 426, 428 face oneanother to form a vein knife passage 430. The channels 426, 428 may bespaced apart from one another at least in part and still form the veinknife passage 430; that is, the vein knife passage 430 need not bebounded around its entire periphery. Alternately, the channels 426, 428are oriented and aligned differently, and/or the vein knife passage 430is formed differently. Each vein knife passage 430 is oriented suchthat, when the tissue effector 40 is in the closed position, thelongitudinal centerline of the vein knife passage 430 is substantiallyparallel to the longitudinal axis of the anvil 10. Alternately, the veinknife passages 430 are aligned differently relative to the longitudinalaxis of the anvil 10 when the tissue effector 400 is in the closedposition.

Referring also to FIG. 62, at least one vein knife passage 430 isconfigured to receive a corresponding vein knife 432. The fit betweenthe dimensions of the vein knife 432 and the corresponding vein knifepassage 430 is close enough that the vein knife passage 430 guides thevein knife 432 and substantially prevents wobbling or other disruptionof the motion of the vein knife 432 as it travels along the vein knifepassage 430, and loose enough to allow the vein knife 432 to slideeasily along that vein knife passage 430 substantially without bindingor interference. Each vein knife 432 has a blade 434 or other sharpelement at its distal end. The blade 434 of at least one vein knife 432may be angled. Alternately, the blade 434 of at least one vein knife maybe curved or otherwise shaped. The proximal end of each vein knife 432is connected to a sled, which is described in greater detail below. Thevein knife 432 is configured to translate or otherwise move between afirst position and a second position. In the first position, the blade434 of the vein knife 432 is located proximal to the flap 408 heldbetween the graft clip 412 and the flap receiving surface 406. The veinknife 432 translates or otherwise moves to the second position and cutsthe flap 408 as it does so. In the second position, the blade 434 of thevein knife 432 is located adjacent or distal to the portion of the flap408 held between the graft clip 412 and the flap receiving surface 406.The first and second positions are reversed when the vein knife 432 ismoved in the opposite direction. Alternately, at least one vein knife432 and corresponding vein knife passage 430 is omitted, and at leastone flap 408 is released from the staple holder 38 after anastomosissimply by opening the corresponding graft clip 412.

Optionally, one or more graft clip blades 436 are connected to at leastone graft clip 412. Referring also to FIG. 63, one or more of the graftclip blades 436 may be serrated. Each graft clip blade 436 is located inand against one side of the first channel 426, such that it does notinterfere with the motion of the vein knife 432. Alternately, one ormore graft clip blades 436 are located in a different position on thecorresponding graft clip 412 or arm 402. Serrations 438 on the graftclip blade 436 are oriented toward the open face of the first channel426 in the graft clip 412. The serrations 438 may be sized and shaped inany appropriate manner. The serrations 438 assist in holding the flap408 between the graft clip 412 and the flap receiving surface 406. Thatis, one or more of the serrations 438 may penetrate into or through theflap 408, thereby holding the tissue of the flap 408 substantially fixedrelative to the graft clip 412 and the flap receiving surface 406. Whenthe vein knife 432 translates along the vein knife passage 430 to incisethe flap 408, the serrations 438 hold the flap 408. The motion of thevein knife 432 may apply stress to the tissue of the flap 408 such thatthe serrations 438 themselves act to cut the tissue of the flap 408.Thus, the cutting action may be a scissors-like action resulting fromthe relative motion of the vein knife 432 and the graft clip blade 436.More than one graft clip blade 436 can be provided in at least one veinknife passage 430. For example, two graft clip blades 436 may be locatedin one first channel 426, in and against two different sides of thefirst channel 426 and spaced apart from one another a sufficientdistance to allow the vein knife 432 to slide therebetween. Otherconfigurations or numbers of graft clip blades 436 may be utilized, ifdesired.

Alternately, referring to FIG. 59D, at least one graft clip 412 may havea thinner cross-section than the graft clip 412 of FIGS. 59-59B. Thisthinner cross-section may be achieved by utilizing metal, such as sheetmetal, to form at least part of the graft clip 412. However, metal neednot be used in order for the graft clip 412 to be made thinner. As shownin FIG. 59C, the graft clip 412 may be an assembly having a first piece407 connected to a second piece 409. The first piece 407 is located ator near the first channel 426 of the graft clip 412. Alternately, thegraft clip 412 may be a single piece, or may be an assembly havingadditional components. The second piece 409 may be made of plastic orany other suitable material. Other materials may be used to form thepieces 407, 409 if desired. Advantageously, the graft clip blades 436may be formed into the first piece 407, particularly where at least thefirst piece 407 of the graft clip 412 is metal. By forming the graftclip blades 436 into a portion of the graft clip 412 rather thanconnecting them to the graft clip 412, construction of the graft clip412 may be simplified.

The use of a thinner graft clip 412 results in less compression of thesurface of the heart, where the target vessel is a coronary artery andthe anvil arm 14 is inserted into that coronary artery. The verticaldistance between the bottom of the anvil arm 14 and the bottom of thegraft clip 412 substantially defines the distance across which the hearttissue near the coronary artery is compressed as the tissue effector 400moves from the open to the closed position. By decreasing that distance,the heart tissue around the coronary artery is compressed a lesserdistance. As a result, the amount of force required to move the tissueeffector 400 from an open position to a closed position, in whichcompressive force is applied against the heart tissue, may be decreased.This reduction in force may simplify the construction of the tissueeffector 400.

Graft Vessel Handling Features—Graft Affixer

Optionally, referring to FIGS. 130-133, a graft affixer 910 is connectedto or formed into the staple holder 38. The graft affixer 910 extendsoutward from the staple holder 38, and is oriented at least partiallytoward the anvil 10. The graft affixer 910 penetrates an end of thegraft vessel 404 and holds the graft vessel 404 to the staple holder 38,as described in greater detail below. The graft affixer 910 may be anystructure or mechanism configured to hold the graft vessel 404 to thestaple holder 38. As one example, the graft affixer 910 may be a spike.The tip of the spike may be oriented toward the anvil 10, or in adifferent direction. As another example, the graft affixer 910 may be ahook. As another example, the graft affixer 910 may be a clip. The graftaffixer 910 may include a barb (not shown) at or near its tip, or at adifferent location, in order to hold the graft vessel 404 more securely.

The graft affixer 910 is located between the arms 402 of the stapleholder 38 slightly proximal to the two most-proximal connector bays 448.This proximal position of the graft affixer 910 allows the graft affixer910 to engage a location on the graft vessel 404 that will be positionedat or near the heel of the anastomosis. Alternately, the graft affixer910 is located directly between the two most-proximal connector bays448. Alternately, the graft affixer 910 is located between the arms 402of the staple holder 38, between or slightly distal to the two mostdistal connector bays 448. If so, the anvil arm 14 may be inserted intothe target vessel 580 in the opposite direction, such that the graftaffixer 910 engages a location on the graft vessel 404 that will bepositioned at or near the toe of the anastomosis. Alternately, the graftaffixed 910 is located at any other suitable location relative to thestaple holder 38.

The graft affixer 910 may be composed of any appropriate material. Asone example, the graft affixer 910 may be composed ofplastically-deformable material, such as stainless steel. As anotherexample, the graft affixer 910 may be composed at least in part of anelastic or superelastic material, such as nickel-titanium alloy.

The graft affixer 910 may be connected to the staple holder 38 in anyappropriate manner. Referring also to FIGS. 131-132, the graft affixer910 may be part of a graft affixer assembly 912. The graft affixerassembly 912 includes a base 914 connected to the graft affixer 910 byan arm 916. The base 914 engages the staple holder 38, such as by afriction fit. Alternately, the base 914 engages the staple holder 38 ina different way. The base 914 may be located proximal to the graftaffixer 910 where the graft affixer 910 is positioned at or near themost proximal connector bays 448 or distal to the graft affixer 910where the graft affixer 910 is positioned at or near the most distalconnector bays 448. Alternately, the base 914 is positioned differentlyrelative to the graft affixer 910. The arm 916 cantilevers the graftaffixer 910 into the space between the arms 402 of the staple holder 38.The arm 916 may be shaped in any manner that connects the base 914 tothe graft affixer 910 and that does not interfere with the operation ofthe tissue effector 400. Alternately, the graft affixer 910 isdetachably connected to the staple holder 38, such as by a clip.

At least part of the graft affixer assembly 912 may be movable relativeto the staple holder 38. Initially, the graft affixer assembly 912 has afirst position relative to the staple holder 38 such that the graftaffixer 910 extends outward from it by a first distance, far enough toallow the graft vessel 404 to be connected to it easily. The graftaffixer assembly 912 is movable to a second position relative to thestaple holder 38 such that the graft affixer 910 extends outward fromthe staple holder 38 by a second distance that is less than the firstdistance. In the second position, the graft affixer 910 still extendsoutward far enough to hold the graft vessel 404, but not so far as tointerfere with the anvil 10 when the tissue effector 400 is in theclosed position. At least part of the graft affixer assembly 912 may bemoved from its initial position to a final position by contact betweenthe base 916 and the anvil 10. For example, the base 916 may befriction-fit to an aperture 918 in the staple holder 38, such thatcontact between the anvil 10 and the base 916 overcomes the frictionalforce holding the base 916 to the aperture and causes the base 916 toslide within the aperture 918. As another example, the graft affixerassembly 912 may be biased toward a stop 920 defined in the stapleholder 38, such that contact between the anvil 10 and the base 916 movesthe graft affixer assembly 912 against that bias away from the stop 920.As another example, the base 916 remains substantially stationary as theanvil 10 moves toward the staple holder 38, and contact between theanvil 10 and the graft affixer 910 moves the graft affixer 910 away fromthe anvil 10 and/or deforms the graft affixer 910. Alternately, thegraft affixer 910 is molded into, formed as an integral part of, gluedonto, welded onto, fastened onto, or otherwise associated with thestaple holder 38 directly, without the use of a graft affixer assembly912.

Referring to FIG. 158, another example of a graft affixer 910 is shown.The graft affixer 910 of FIG. 158 is detachable from the staple holder38, and/or may be used to provide additional sealing at the heel 587 ofthe anastomosis. The exemplary graft affixer 910 of FIG. 158 may also bereferred to as the heel clip 910. The heel clip 910 includes a leg 1150having a free end 1152. The free end 1152 of the leg 1150 may besubstantially sharp or substantially blunt. A first tab 1154 extendsoutward from the leg 1150 of the heel clip 910. Alternately, the firsttab 1154 extends from a different part of the heel clip 910. Moving awayfrom the free end 1152 of the heel clip 910, a base 1156 of the heelclip 910 bends or angles away from the leg 1150. A second tab 1158extends outward from the base 1156 of the heel clip 910. Alternately,the second tab 1158 extends from a different part of the heel clip 910.Continuing along the heel clip 910 away from the free end 1152 of theleg 1150, a prong 1160 extends from the base 1156. The prong 1160 may beoriented in substantially the same direction as the leg 1150.Alternately, the prong 1160 is oriented in a different direction fromthe leg 1150. The prong 1160 has a free end 1162 that may besubstantially sharp or substantially blunt. The heel clip 910 may befabricated from a single unit of material. Alternately, at least part ofthe heel clip 910 is fabricated separately and connected to a remainderof the heel clip 910 in any suitable manner, such as by welding.

The heel clip 910 is detachable from the staple holder 38, and may bedetachably held by the staple holder 38 in any suitable manner. As oneexample, the staple holder 38 includes a ledge 1162 that engages thefirst tab 1154 and a notch 1164 that engages the second tab 1158. Theledge 1162 and the notch 1164 may be configured to hold the tabs 1154,1158 such that the heel clip 910 is compressed at least slightly,thereby enhancing the connection between the heel clip 910 and thestaple holder 38. The staple holder 38 may include a pocket 1157 orother surface or feature configured to receive at least part of the base1156 of the heel clip 910. Alternately, the heel clip 910 may bedetachably connected to the staple holder 38 in any other suitablemanner.

Graft Vessel Handling Features—Measurement Feature

Referring also to FIG. 130, the staple holder 38 includes at least onemeasurement feature 922. Advantageously, two measurement features 922are provided, one on each arm 402 of the staple holder 38, each havingsubstantially the same length. Each measurement feature 922 is locatedon the staple holder 38 in such a way as to facilitate the placement ofthe graft vessel 404 relative to the staple holder 38, as described ingreater detail below. Each measurement feature 922 may be shaped orconfigured in any suitable manner. For example, at least one measurementfeature 922 is a raised area on an arm 402 of the staple holder 38,positioned relative to the graft affixer 910 to be able to assist in thepositioning of the graft vessel 404 relative to the staple holder 38.Alternately, at least one measurement feature 922 is a depressed area onan arm 402 of the staple holder 38, one or more indicia defined on anarm 402 of the staple holder 38, or any other appropriate structure ormechanism. Alternately, at least one measurement feature 922 isconfigured differently. The measurement feature 922 has two spaced-apartends. Alternately, at least one measurement feature 922 is twospaced-apart and unconnected indicia.

Staple Holder Components

Referring also to FIG. 64, a cross-section of one arm 402 of the stapleholder 38 is shown. The staple holder 38 is substantially symmetrical,such that the arm 402 shown is substantially a mirror image of the otherarm 402. Alternately, the staple holder 38 is not symmetrical, and/orthe arms 402 are not mirror images of one another. A passage 440 isdefined within each arm 402. Each passage 440 extends substantiallylongitudinally within the corresponding arm 402, and the longitudinalcenterline of each passage 440 is substantially parallel to thelongitudinal centerline of the anvil 10 when the tissue effector 400 isin the closed position. Alternately, at least one passage 440 isoriented differently relative to its corresponding arm 402. The passage440 may have a rectangular cross-section, or a different cross-section.Further, the dimensions of the passage 440 may be substantially constantalong its entire length, or may change along at least part of itslength. Optionally, the distal end 442 of the passage 440 is open,and/or the proximal end 444 of the passage 440 is open.

A ramp element 446 is configured to translate or otherwise move throughat least a portion of each passage 440. Referring also to FIGS. 68-69A,the ramp elements 446 may be molded or otherwise formed into a unitaryramp element assembly 484, or may be molded or otherwise formedseparately and then connected together. Alternately, the ramp elements446 are not connected to one another. The ramp elements 446 may beformed from stainless steel, polymer or other appropriate material. Thevein knives 432 are connected to the ramp element assembly 484 to form asled 482. As an example, apertures 486 are defined in the ramp elementassembly 484, and the proximal end of each vein knife 432 is sized andshaped to provide for a pressure or interference fit within thecorresponding aperture 486. However, any other appropriate mechanism,structure or method may be used to connect each vein knife 432 to theramp element assembly 484. Alternately, the ramp elements 446 and thevein knives 432 are cast, molded or otherwise formed as a single unit.The vein knives 432 may be fixed to the ramp element assembly 484, suchthat the ramp elements 446 and the vein knives 432 translate as a unitsubstantially simultaneously. Alternately, at least one ramp element 446is moveable relative to at least one vein knife 432, or vice versa. Asanother example of the sled 482, each ramp element 446 is connected tothe corresponding vein knife 432, but the ramp elements 446 are notconnected to one another.

The sled 482 includes an attachment feature 488. The attachment feature488 may be an aperture through a portion of the ramp element assembly484 that is configured to receive a second cable 490 or other forcetransmission mechanism or structure. Where a cable is used and theattachment feature 488 is an aperture, the second cable 490 may beinserted into and/or through the attachment feature 488, and held inplace there such as by tying off one end of the cable, by welding, byadhesive, or any other appropriate connection method. Alternately, theattachment feature 488 may be a ring, a hook, a raised area, adepression, or any other structure or mechanism appropriate forconnection to a cable or other force transmission mechanism orstructure.

One or more connector bays 448 are defined in each arm 402, between thepassage 440 within the arm 402 and an inner surface 450 of the arm 402.The connector bays 448 and the passages 440 are substantially hollow.The cross-sectional shape of each connector bay 448 is selected to allowit to receive and hold a staple or other connector, as described below.The connector bays 448 are oriented such that the longitudinalcenterline of each connector bay 448 is substantially perpendicular tothe longitudinal centerline of the corresponding passage 440.Alternately, at least one connector bay 448 is oriented differentlyrelative to the corresponding passage 440. Each connector bay 448 hassubstantially the same cross-section and length. Alternately, at leastone connector bay 448 has a different cross-section and/or length thanat least one other connector bay 448. The connector bays 448 may beoriented relative to a local horizontal such that the longitudinalcenterline of each connector bay 448 forms an angle of between 0.degree.and 45.degree. relative to that local horizontal. (The use of the term“horizontal” here and elsewhere in this document is used for conveniencein description only, and does not restrict the orientation in which theanastomosis tool 300 may be used.) A different orientation may be used,if desired. As one example, the longitudinal centerline of eachconnector bay 448 may form an angle of greater than 45.degree. relativeto the local horizontal, as shown in FIG. 123. Such an angle may holdthe lateral sides of the anastomosis closer together and thus mayenhance sealing. To facilitate deployment at such an angle, bendingfeatures 572 on the anvil arm 14 may be located on an upper surface ofthe anvil arm 14 instead of its sides, as shown in FIG. 124. The bendingfeatures 572 correspond to the connector bays 448, each receiving an endof at least one connector 464 and facilitating its bending ordeformation to a deployed configuration. Alternately, the bendingfeatures 572 may be positioned differently on the anvil arm 14.Alternately, at least one of the bending features 572 may be omitted.Where the connector bays 448 are significantly angled relative to thelocal horizontal, the arms 402 of the staple holder 38 may be madenarrower, facilitating the use of the tissue effector 400 in bothopen-chest and closed-chest surgery.

Referring also to FIG. 65, at least one connector bay 448 is configuredto receive a connector deployer 452. Each connector bay 448 is shaped toallow the corresponding connector deployer 452 to translate or otherwisemove within it. The connector deployers 452 may be shaped in anyappropriate manner. As one example, a connector deployer 452 issubstantially curved at its outer end 454 and substantially flat at itsinner end 456. The connector deployer 452 may vary in height along atleast a portion of its length and/or width. As one example, aregistration element 458 may extend upward from the upper surface 460 ofthe connector deployer 452. The registration element 458 may be formedinto the connector deployer 452, or otherwise manufactured into it orconnected to it.

Where a registration element 458 is used, the corresponding connectorbay 448 is shaped accordingly. That is, the size, shape and orientationof the registration element 458 of the connector deployer 452corresponds to the size, shape and orientation of a registration feature462 of the connector bay 448. For example, where the connector deployer452 and registration element 458 of FIG. 65 is used, the correspondingconnector bay 448 is shaped as shown in FIG. 66. The registrationelement 458 translates along the registration feature 462 as theconnector deployer 452 translates along the connector bay 448. In thisway, the connector deployer 452 is maintained in a desired orientationthroughout its translation relative to the connector bay 448, and theconnector deployer 452 is prevented from cocking in the connector bay448 during that translation. The connector deployers 452 andcorresponding connector bays 448 may be shaped differently, if desired.The connector deployers 452 are all shaped substantially identically.Alternately, at least one of the connector deployers 452 is shapeddifferently from at least one of the others, and the correspondingconnector bay or bays 448 are shaped accordingly. Optionally, abiocompatible lubricant such as sodium stearate may be used between atleast one connector deployer 452 and the corresponding connector bay 448to facilitate the translation of the connector deployer 452 relative tothe connector bay 448.

Where multiple connector bays 448 are provided in each arm 410, at leastthe most-proximal and/or the most distal connector bays 448 may beoffset relative to the other connector bays 448. Advantageously, thedirection of offset is toward the longitudinal centerline of the anvilarm 14, as determined when the tissue effector 400 is in the closedposition. Each connector bay 448 on one arm 410 may be at substantiallythe same longitudinal position on the arm as a corresponding connectorbay 448 on the other arm 410. In this way, connector bays 448 onopposite arms 410 may be said to be paired. The two connector bays 448in the most-proximal and/or most distal pair may be spaced apart fromone another a distance less than the spacing between connector bays 448in at least one of the remaining pairs, as a result of the offset of themost-proximal and/or most distal connector bays 448. As a result, theconnectors 464 deployed by the most-proximal and/or most distalconnector bays 448 may be spaced apart from one another by a lesserdistance than exists between connectors 464 deployed from the remainingpairs of connector bays 448. Referring also to FIG. 135, this reducedspacing may enhance the seal of the anastomosis at its heel 587 and/ortoe 585.

Each connector deployer 452 is moveable between a first position and asecond position. In the first position, the outer end 454 of theconnector deployer 452 extends at least partially into the passage 440.Alternately, the outer end of the connector deployer 452 does not extendinto the passage 440. In the second position, the connector deployer 452has translated relative to the corresponding connector bay 448 andcompleted its motion. The outer end 454 of the connector deployer 452 nolonger extends into the passage 440. Alternately, the outer end 454 ofthe connector deployer 452 still extends into the passage 440 in thesecond position. Each connector deployer 452 translates or otherwisemoves from the first position to the second position as a result ofcontact with the ramp element 446. This translation is described ingreater detail below.

Referring also to FIG. 156, optionally, a biasing element 453 may beconnected to or associated with at least one connector deployer 452. Asone example, the biasing element 453 may be a coil spring. However, thebiasing element 453 may be any other type of spring, or any othersuitable structure or mechanism. The biasing element 453 may be moldedinto or otherwise connected to the corresponding connector deployer 452.The biasing element 453 may include a free end oriented substantiallytoward the anvil arm 14 when the tissue effector 400 is in the closedposition. The longitudinal centerline of the biasing element 453 may besubstantially parallel to the longitudinal centerline of thecorresponding connector deployer 452. Alternately, the biasing element453 may be oriented differently. A stop 455 is defined near the exit ofthe connector bay 448, or at any other suitable location along thelength of the connector bay 448. The stop 455 is sized and positionedsuch that the biasing element 453 contacts the stop 455 as the connectordeployer 452 is urged toward the anvil arm 14 to deploy thecorresponding connector 464. Contact between the biasing element 453 andthe stop 455 compresses the biasing element 453 or otherwise storesenergy in the biasing element 453. Part of at least one connectordeployer 452 may extend out of the corresponding connector 448 afterthat connector deployer 452 has deployed the corresponding connector464. After that deployment, the stored energy in the biasing element 453urges the connector deployer 452 away from the anvil arm 14 and awayfrom the exit opening of the corresponding connector bay 448. In thisway, at least part of at least one connector deployer 452 is moved backinto the corresponding connector bay 448 and out of the space betweenthe arms 402 after that connector deployer 452 deploys a connector 464.Alternately, more than one biasing element 453 is associated with atleast one connector deployer 452. Alternately, in at least one connectorbay 448, the biasing element 453 is connected to the connector bay 448,and the stop 455 is positioned on the corresponding connector deployer452. Alternately, a single biasing element 453 may be connected to botha connector deployer 453 and the corresponding stop 455. Alternately, abiasing element 453 may be connected to the stop 455, and anotherbiasing element 453 may be connected to the corresponding connectordeployer 452, such that the two biasing elements 453 engage one anotheras the connector deployer 452 is urged toward the anvil arm 14.

A connector 464 is placed in at least one connector bay 448. Eachconnector 464 may be any suitable anastomotic connector. In an exemplaryembodiment shown in FIG. 64, the connector 464 is a staple. Eachconnector 464 is located closer to the inner surface 450 of the arm 402than the corresponding connector deployer 452. The connector 464 may beconfigured as disclosed in pending U.S. patent application Ser. No.10/309,519, filed Dec. 4, 2002, now U.S. Pat. No. 7,267,682, issued Sep.11, 2007, which patent is hereby incorporated herein by reference in itsentirety. Referring also to FIG. 67, the connector 464 may include fourtines 466 extending from a base 468. The tines 466 may be offset fromone another. A different configuration of connector 464 may be used, ifdesired. For example, at least one connector 464 may be a conventionalwire staple. The connectors 464 utilized may be all of the same type, ordifferent types of connectors 464 may be mixed within the staple holder38. The connector 464 is constructed from 316L stainless steel, but maybe constructed from a different type of stainless steel, or from adifferent material. For example, at least one connector 464 may beconstructed from superelastic material, such as nickel-titanium alloy.Such a connector 464 may be self-deformable from an undeployed state toa deployed state. As another example, the connector 464 may be aconnector other than a staple, such as a pin or clip. As anotherexample, a single connector 464 may be detachably connected to at leastone arm 402. The single connector 464 includes tines 466 spaced apartfrom one another along a base 468. The base 468 of the single connector464 is longer than the base 468 of the exemplary connector 464 describedabove. Advantageously, the base 468 is sized to be substantially as longas the corresponding flap 408, although the base 468 may be longer orshorter if desired. The tines 466 extend from the base 468 at intervalsalong the base 468. Advantageously, the single connector 464 replaces aplurality of individual connectors 464 that otherwise would be deployedfrom the arm 402, and the location of the tines 466 along the base 468substantially matches the locations where the tines 466 of theindividual connectors 464 would have been located. Where the singleconnector 464 is utilized, the connector bays 448 and structures andmechanisms associated with the connectors' bays 448 may be omitted. Inthis way, fabrication and/or operation of the tissue effector 400 may besimplified.

Each connector 464 is oriented in the connector bay 448 such that thetines 466 extend in a direction facing substantially out of theconnector bay 448. Alternately, at least one connector 464 is orienteddifferently. The base 468 of the connector 464 may be in contact withthe inner end 456 of the corresponding connector deployer 452 when thatconnector deployer 452 is in the first position, or may be spaced apartfrom the inner end 456 of that connector deployer 452 in the firstposition. When the connector deployer 452 is in the first position, thecorresponding connector 464 is held within the connector bay 448 in anyappropriate way. Referring also to FIG. 66, as one example, the tines466 of each connector 464 may be biased against at least part of thecorresponding connector bay 448. For example, at least one tine 468 maybe biased against a lower surface 470 of the connector bay 448 and atleast one other tine 469 may be biased against an upper surface 472 ofthe connector bay 448. The biasing force exerted by each tine 468against the corresponding surface 470, 472 of the connector bay 448holds the connector 464 in place when the connector deployer 452 is inthe first position. The biasing forces exerted by the tines 468 are highenough to hold the connector 464 securely within the connector bay 448,and are low enough to allow the connector 464 to translate easily as aresult of contact with the corresponding connector deployer 452. Asanother example, each connector 464 may be held in place in thecorresponding connector bay 448 with a biocompatible substance thatprovides friction between that connector 464 and the connector bay 448,where the amount of force required to overcome that friction and movethe connector 464 is selected to be less than the amount of deploymentforce to be exerted on the connector 464 by the corresponding connectordeployer 452. The translation of a connector deployer 452 from the firstposition to the second position causes deployment of the correspondingconnector 464, as described in greater detail below.

The ramp element 446 translates or otherwise moves within the passage440, as described above. The distal end 474 of the ramp element 446 isconfigured to engage the outer ends 454 or other parts of the connectordeployers 452 as it moves, causing those connector deployers 452 in turnto translate or otherwise move relative to their respective connectorbays 448. As one example, the ramp element 446 is curved and/or angledat its distal end 474, where the curvature and/or angularity begins ator near the most distal point of the ramp element 446 and continuesproximally along the inner surface 476 of the ramp element 446. That is,the ramp element 446 increases in width from its most distal point to aselected point spaced apart from and proximal to that most distal point.The ramp element 446 may be shaped such that the curvature and/orangularity of the distal end 474 is present on the inner surface 476 ofthe ramp element 446, and such that the outer surface 478 of the rampelement 446 is substantially flat against a wall of the passage 440. Theramp element 446 may be smoothly curved, along an arc, spline, or anyother suitable curve that may have no inflection points or one or moreinflection points. However, the ramp element 446 may be shaped in anyother appropriate manner. The ramp element 446 may be translateddistally along at least a portion of the passage 440. In the course ofthis translation, the distal end 474 of the ramp element 446sequentially contacts at least the outer ends 454 of, and therebyactuates, the connector deployers 452, beginning with the most proximaland concluding with the most distal. Alternately, the ramp element 446translates proximally to contact and actuate sequentially the connectordeployers 452, beginning with the most distal and concluding with themost proximal. That is, the sled 482 may translate or otherwise moveeither distally or proximally to actuate the connector deployers 452.Alternately, the ramp element 446 is configured to move in such a mannerthat at least a component of its motion is toward the inner surface 450of the arm 402, such that the ramp element 446 engages more than oneconnector deployer 452 at a time. Thus, the ramp element 446, anothercomponent of the sled 482, or a different component may actuate theconnector deployers 452 serially or in parallel.

Optionally, one or more of the connector deployers 452 are omitted fromthe tissue effector 400, such that the ramp element 446 and/or adifferent component of the sled 482 directly contacts one or more of thestaples 464 to urge that staple or staples 464 out of the correspondingarm 402. That is, the intermediate mechanism between the sled 482 and atleast one of the staples 464 may be omitted. If so, the sled 482 and/orat least one connector 464 are configured such that contact between themurges the connector 464 in the desired direction. For example, one ormore of the staples 464 may include a structure analogous to theconnector deployer 452 formed into it, where that structure is implantedinto the patient along with the connector 464. This additional structureis small, and is positioned outside the lumen of both the graft vesseland the target vessel, such that its presence in the patient has noeffect. Such a structure may be composed of stainless steel or otherbiocompatible material, or from bioabsorbable material that is graduallyabsorbed by the patient. Such biocompatible and bioabsorbable materialsare standard in the art.

Optionally, one or more of the connector bays 448 may be omitted fromone or more of the arms 402 of the staple holder 38. For example, if thestaples 464 are deployed in parallel, the staples 464 may be connectedto the sled 482 or other component such as by adhesive, where thatconnection is able to withstand an amount of force less than the forcewith which the deployed connector 464 grips the graft vessel 404 and thetarget vessel 580. As a result, after the staples 464 are deployed intotissue and grip the vessels 404, 580 and the sled 482 or other componentis pulled away from the anastomosis, the connection between eachconnector 464 and the sled 482 or other component is broken, therebyfreeing the staples 464 from the staple holder 38.

Cables, Cable Housing, and Shaft

Referring also to FIGS. 58 and 74, the anvil 10 may be connected to aforce transmission mechanism such as a first cable 480. As describedabove, the anvil 10 may include a cutter stop 236 having one or moreattachment features 270 to which the first cable 480 is connected.However, the first cable 480 may be connected to a different or anadditional part of the anvil 10.

The sled 482 is connected to a force transmission mechanism such as asecond cable 490. As described above, the sled 482 includes anattachment feature 488 to which the second cable 490 is connected.However, the second cable 490 may be connected to a different or anadditional part of the sled 482. Alternately, one or both of the cables480, 490 are not used, and a different force transmission mechanism isused instead. For example, one or both force transmission mechanisms maybe a chain, a shaft, one or more gears, one or more tubes for handlingpressurized gas or vacuum, conductive elements for carrying electricity,and/or other appropriate mechanisms.

Alternately, the tissue effector 400 may be configured differently,and/or the cables 480, 490 may be attached to the tissue effector 400differently. As one example, referring to FIG. 154, the first cable 480extends through part of the anvil 10 and is then connected to the stapleholder 38. An axle 1082 may be defined in or connected to the anvil 10.The first cable 480 may be routed along a path that, moving distally,travels along a portion of the anvil 10, then under the axle 1082, thendistal to the axle 1082, then upward to the staple holder 38, where thatfirst cable 480 may be connected to the staple holder 38 in any suitablemanner. As one example, an end of the first cable 480 is connected to antermination element 1084. The termination element 1084 is wider than anaperture or passage 1086 in the staple holder 38 through which a portionof the first cable 480 enters. The termination element 1084 is on theother side of the aperture or passage 1086 than the anvil 10. Thus, thetermination element 1084 prevents the first cable 480 from slipping outof the aperture or passage 1086. Alternately, the end of the first cable480 may be knotted, forming a knot having a diameter larger than that ofthe aperture or passage 1086; the termination element 1084 is omitted.Alternately, the first cable 480 may be connected to the staple holder38 in any other suitable manner. The first cable 480 is routed throughthe tissue effector 400 in such a way that tension exerted on the firstcable 480 causes the tissue effector 400 to move to the closed position.The axle 1082 acts to convert proximal motion of the first cable 480into force acting downward on the staple holder 38.

The second cable 490 may also, or instead, be configured in the tissueeffector 400 in a different manner. As one example, referring to FIG.154, the second cable 490 may be connected to the sled 482, or astructure or mechanism connected to or associated with the sled 482, inany suitable manner. A termination element 1084 may be utilized inconjunction with an aperture or passage 1088 in the sled 482 or astructure or mechanism connected to or associated with the sled 482. Thetermination element 1084 may be as described above with regard to thetermination element 1084 of the first cable 480. Alternately, the end ofthe second cable 490 may be knotted, forming a knot having a diameterlarger than that of the aperture or passage 1088; the terminationelement 1084 is omitted. The second cable 490 is routed through thetissue effector 400 in such a way that tension exerted on the secondcable 490 causes the sled 482 to move, thereby causing the staple holder38 to deploy a plurality of connectors 464.

The sled 482, or a structure or mechanism connected to the sled 482, mayinclude a receiver 218 At least part of the receiver 218 may be orientedat least partially toward the anvil 10. Alternately, the receiver 218 isoriented differently. The receiver 218 is configured to engage theengagement member 216 extending from the cutter 200, such that motion ofthe sled 482 causes the receiver 218 to move the engagement member 216and thus the cutter 200. The receiver 218 and the engagement member 216may be shaped, sized and/or configured in any manner that allows them toengage one another upon and/or after actuation of the first cable 480when the tissue effector 400 is in the closed position. As one example,the engagement member 216 may be a protrusion in an upper portion of thecutter 200, and the receiver 218 may be a protrusion that extendssubstantially downward, such that when the tissue effector 400 is in theclosed position the receiver 218 is aligned with, and extends lower thanan upper part of, the engagement member 216, such that proximal motionof the receiver 218 causes the receiver 218 to contact the engagementmember 216 and urge it proximally.

Optionally, a cutter slide 1092 may be slidable along at least part ofthe anvil 10. The cutter slide 1092 may be part of the cutter 200, orconnected to the cutter 200. The cutter slide 1092 includes a engagementmember 216. As one example, the engagement member 216 may be a step orshoulder in an upper portion of the cutter slide 1092. The cutter slide1092 may be connected to a cutter pull 1096 in any suitable manner. Asone example, a crimp 1098 may be used to crimp the cutter pull 1096 tothe cutter slide 1092. However, any other structure, mechanism or methodmay be used to connect the cutter pull 1096 to the cutter slide 1092.The cutter pull 1096 may be a wire fabricated from stainless steel,nitinol or any other suitable metallic or nonmetallic material.Alternately, the cutter pull 1096 may be a cable or other structure ormechanism. The cutter pull 1096 is also connected to the cutter 200and/or the projection 208. In this way, motion of the cutter slide 1092causes the cutter 200 and/or the projection 208 to move, as described ingreater detail below.

Referring also to FIGS. 58, 74, the cables 480, 490 extend proximallyfrom the tissue effector 400. Optionally, a cable housing 306 isprovided. The cable housing 306 is a tube that is at least partiallyflexible, through which at least a portion of the cables 480, 490extend. Two or more lumens or passages may be present in the cablehousing 306, such that each cable 480, 490 extends through a differentlumen or passage of the cable housing 306. Referring also to FIG. 57,the staple holder 38 may include a collar 492. The collar 492 may beformed into the staple holder 38, or formed separately from and attachedto the staple holder 38. The collar 492 includes a passage 494therethrough. The diameter of the passage 494 may be substantially thesame as the outer diameter of the cable housing 306, such that thedistal end of the cable housing 306 may be received into and/or throughthe collar 492 and held therein. Similarly, the shape of the passage 494may substantially correspond to the shape of the distal end of the cablehousing 306. The distal end of the cable housing 306 is fixed to thecollar 492 via a friction fit, adhesive, welding, or any otherappropriate structure, mechanism or method. The cable housing 306 neednot have a uniform shape, size or cross-section along its entire length.Alternately, the distal end of the cable housing 306 may connect to adifferent portion of the tissue effector 400, or may not connect to thetissue effector 400 at all. Additionally, the cable housing 306 may passover and/or connect to one or more of the connection members 280 of thetissue effector 400, and/or one or more other components of the tissueeffector 400.

One or more channels 496 may be defined on the surface of the stapleholder 38 distal to the collar 492. Each channel 496 receives a cable480, 490. At least one channel 496 may be curved in a convex manner,such that the corresponding cable 480, 490 curves as well. The convexcurvature causes the most distal part of that channel 496 to be locatedbetween the upper and lower ends of the channel 496. The cable 480, 490in that channel 496 may be under tension, such that it follows thecurvature of that channel 496. Thus, each channel 496 causes the cable480, 490 received therein to curve back in a proximal direction. Forexample, the second cable 490 is connected to the sled 482. Tension onthe second cable 490 that results from proximal motion of its proximalend also results in distal motion of the sled 482.

Cables, Cable Housing, and Shaft—Shaft Articulation

The shaft 304 may be articulated to allow the tissue effector 400 to beplaced in two or more different orientations relative to the handle 302.As one example of articulation, referring also to FIG. 56, the shaft 304may be bifurcated at its distal end, forming two spaced-apart arms 305.The cable housing 306 passes between the arms 305, such that the arms305 constrain the potential lateral motion of the cable housing 306.Alternately, the cable housing 306 does not pass between the arms 305.At least one arm 305 forms or connects to a paddle 307 at its distalend. The cable housing 306 extends in a curved configuration, such as anS-shaped or serpentine configuration, between the shaft 304 and thetissue effector 400. The paddle or paddles 307 may be substantiallyplanar and parallel to one another. A receiving opening 309 is providedthrough at least one paddle 307, each opening corresponding to a cog 282of the tissue effector 400. One or more detents 310 are present alongthe perimeter of the receiving opening 309, corresponding to the teeth284 of the cog 282. The teeth 284 are configured to engage the detents310 in the receiving opening 309. The button 278 connected to the cog282 may be connected to the spine 272 with a single connection member280 spaced apart from the cog 282, or may be connected to the spine 272with one or more flexible connection members 280. As a result, thebuttons 278 can be compressed together, such that the teeth 284 aremoved out of engagement with the corresponding detents 310. The cog 282thus can be moved to a position out of contact with the receivingopening 309, such that it is located between the paddles 307.Consequently, the cog 282 and the tissue effector 400 can be freelyrotated to a desired orientation. The buttons 278 are then released,such that the cog 282 re-enters the receiving opening 309 and the teeth284 engage the detents 310 in the receiving opening 309 once again.Alternately, the cog 282 engages a corresponding gear or other structureor mechanism in or on the shaft 304, such that motion of thecorresponding gear rotates the cog 282. Alternately, the cog 282 isconnected to the shaft 304 or one or more components in and/or on theshaft 304 in such a way that the cog 282 can be rotated or otherwisemanipulated as desired. Alternately, the tissue effector 38 is connectedto the shaft 304 with a mechanism or structure other than or in additionto the cog 282.

The cog 282 allows the tissue effector 38 to be oriented at a pluralityof positions relative to the shaft 304. That is, the cog 282 allows thetissue effector 38 to move such that the longitudinal centerline of thetissue effector 38 may be positioned at more than one angle relative tothe longitudinal centerline of the shaft 304. The cog 282 or othermechanism may allow the tissue effector 38 to move smoothly through arange of orientations relative to the handle 302, or may allow thetissue effector 38 to move among two or more discrete orientationsrelative to the handle 302. Thus, the tissue effector 38 is orientableto two or more different positions relative to the handle 302. Therelative motion between the tissue effector 38 and the shaft 304 allowsthe tissue effector 38 to be utilized on target vessels having a numberof different orientations within the patient, while allowing convenientaccess by the surgeon or other medical professional. That is, thesurgeon may hold the handle 302 in a single convenient position, andorient the tissue effector 38 into a selected position relative to theshaft 304 and handle 302 that is optimal for use with a particulartarget vessel. Optionally, the arms 305 or a mechanism connected to thearms may be capable of rotation relative to the shaft 304, providingadditional freedom of motion for the tissue effector 38. Alternately,the cog 282 is not present, and the arms 305 otherwise allow motion ofthe tissue effector 38 relative to the shaft 304. Alternately, thetissue effector 400 is fixed relative to the shaft 304.

Referring also to FIGS. 140-141, another example of an articulated shaft304 is shown. The tissue effector 400 may be connected to the shaft 304by a hinge 956. A locktab 954 may be connected to the shaft 304 and/orthe tissue effector 400 in proximity to the hinge 956. The tissueeffector 400 may include an interface member or members 957 connected tothe hinge 956. The interface member or members 957 may be rounded inproximity to their connection with the hinge 956, and at least oneinterface member 957 may include an aperture 955 therethrough to receivethe hinge 956. Alternately, the tissue effector 400 is connected to theshaft 304 by any other suitable mechanism that allows the tissueeffector 400 to be oriented in two or more discrete positions relativeto the shaft 304. For example, a ball joint may be utilized instead of,or in addition to, the hinge 956. The locktab 954 may be connected tothe shaft 304 and/or the tissue effector 400 in any suitable manner. Asone example, the locktab 954 is itself connected to the shaft 304 by alocktab hinge 958. The locktab hinge 958 may be oriented substantiallyperpendicular to the hinge 956, or may be oriented differently relativeto the hinge 956.

The locktab 954 may be movable from a first position, as shown in FIG.140, to a second position, as shown in FIGS. 141 and 142. When thelocktab 954 is in the first position, the tissue effector 400 isrotatable or otherwise movable relative to the shaft 304, such that thesurgeon may place the tissue effector 400 in a desired position relativeto the shaft 304. When the locktab 954 is in the second position, thetissue effector 400 is substantially locked in place relative to theshaft 304, such that the tissue effector 400 is maintained substantiallyin place during the anastomosis procedure. In the first position, thefree end of the locktab 954 may be spaced apart from the shaft 304, andin the second position, the free end of the locktab 954 may be inproximity to the shaft 304. Alternately, the locktab 954 may be orienteddifferently in the first position and/or the second position.

When the locktab 954 is in the second position, it maintains the tissueeffector 400 substantially in its selected orientation in any suitablemanner. As one example, the locktab 954 may use a cam lock 960 to holditself in the second position. The cam lock 960 may be configuredsubstantially as the cam lock described above that may be utilized tohold at least one graft clip 412 in the closed position. If so, the camlock 960 may include a lobe 962 at or near its distal end. The hinge 956may extend out of the sides of the shaft 304. If so, a first flange 974extends from the hinge 956 on one side of the shaft 304, and a secondflange 976 extends from the hinge 304 on the other side of the shaft 304and on the side of the locktab 954 facing substantially away from theshaft 304. The hinge 956 extends through the walls of the shaft 304, andthrough the apertures 955 of the interface member or members 957. Athird flange 978 may extend outward from the hinge 956 adjacent to atleast one of the interface members 957, where that at least oneinterface member 957 is between the third flange 978 and the locktab954. The locktab hinge 958 may extend through or into part of the hinge956.

As the cam lock 960 rotates about the locktab hinge 958 from the firstposition to the second position, an increasingly greater cross-sectionof the lobe 962 moves between the second flange 976 and the outer wallof the shaft 304. As a result, the second flange 976 is pulled away fromthe outer wall of the shaft 304. At the same time, the third flange 978pulls the interface member or members 957 into contact with the innersurface of the shaft 304 or other part of the shaft 304. After the camlock 960 has moved to the second position, the third flange 978 exertsenough force on the interface member or members 957 such that at leastone interface member 957 is substantially friction-fit against the shaft304. As a result, the tissue effector 400 is substantially restrained ina desired position relative to the shaft 304.

Alternately, where a different mechanism than a hinge 956 is used forarticulation, then the cam lock 960 may exert a force on that mechanismto hold it in place relative to the shaft 304 when the locktab 954 is inthe second position. Alternately, any other suitable structure,mechanism and/or method may be utilized to hold the locktab 954 in thesecond position.

Referring also to FIG. 55, the shaft 304 may be substantially hollowalong at least part of its length, starting at its proximal end andcontinuing distally. The entire shaft 304 may be substantially hollow.An aperture 498 or other opening is located in the wall of the shaft 304at a point along its length where it is hollow. Thus, the aperture 498provides access to the lumen of the shaft 304. The cable housing 306extends through the aperture 498 into the lumen of the shaft 304.Alternately, the cable housing 306 does not enter the lumen of the shaft304, and instead is attached to the outer surface of the shaft 304 withadhesive, clips, pins, and/or any other appropriate attachmentmechanisms, structures or methods. If so, the shaft 304 need not includea lumen. Alternately, the cable housing 306 does not connect to theshaft 304 at all, and instead connects to the handle 302 directly. Ifso, the shaft 304 need not include a lumen, and may be solid.

Handle

The proximal end of the shaft 304 is connected to the handle 302. Thehandle 302 may be configured in any suitable manner. As one example, thehandle 302 may include two or more individual handle shell members 502that are connected to one another. Alternately, the handle 302 may beconstructed differently. The shaft 304 may be fixed to the handle 302such that it does not substantially move relative to the handle 302.Referring also to FIG. 70, as one example, a member 500 extends from onehandle shell member 502 into the hollow interior of the handle 302. Thatmember 500 may connect at its other end to the other handle shell member502. The proximal end of the shaft 304 includes a corresponding aperture504, such that the member 500 fits within the aperture 504. The aperture504 is substantially the same size as the cross-section of the member500. When the shell members 502 are assembled, the member 500 engagesthe aperture 504 of the shaft 304 and holds the shaft 304 in place.Alternately, a member 500 extends from each handle shell member 502, andthose members 500 both engage the aperture 504 of the shaft 304. Asanother example, ribs (not shown) may be defined in the inner surface ofthe handle, and a corresponding retainer (not shown) is defined at ornear the proximal end of the shaft. The retainer is wider than the shaft304, and has a selected thickness. The ribs are spaced apart from oneanother substantially the same distance as the thickness of theretainer. The ribs thus substantially prevent the shaft 304 fromtranslating proximally or distally. The handle 302 may engage theretainer with a registration feature or other structure or mechanism tosubstantially prevent rotation of the shaft 304 about its longitudinalaxis. Alternately, the handle 302 holds the shaft 304 in a differentway.

The handle 302 has a substantially hollow interior. Where the shaft 304includes a lumen, the lumen of the shaft 304 opens into the interior ofthe handle 302. The cables 480, 490 extend out of the lumen of the shaft304 into the hollow interior of the handle 302. Alternately, the cables480, 490 extend through the cable housing 306 directly into the handle302, bypassing the shaft 304.

One or more mechanisms within the handle 302 are utilized to actuate thetissue effector 38 via the cables 480, 490. Alternately, at least someof those mechanisms are separate from the handle 302. Referring to FIGS.70 and 78, one example of such mechanisms is shown. A single input tothe anastomosis tool 300 via the trigger 308 actuates the anastomosistool 300. Alternately, one or more additional inputs to the anastomosistool 300 are required, such as actuation of a safety switch ordepression of a second feature. The trigger 308 initially extendsoutward from the upper surface of the handle 302 through an aperture 506in the handle 302. Alternately, the trigger 308 initially extends from adifferent surface of the handle 302. Alternately, the trigger 308 isinitially flush with the surface of the handle 302, or otherwiseconfigured. The handle 302 may be shaped ergonomically for ease ofoperation. For example, as shown in FIGS. 70 and 78, the handle 302 iscurved and tapered slightly toward its proximal end, and substantiallybilaterally symmetrical, such that the proximal end of the handle 302can be gripped easily with either the left or the right hand.Alternately, the handle 302 may be ergonomically configured in adifferent way for ease of actuation by the user. The trigger 308 ispositioned on the handle 302 such that it can be actuated convenientlyby a user's thumb. Alternately, the trigger 308 could be placed on theunderside of the handle 302 for actuation with the index finger ofeither hand. More than one finger may be used to actuate the trigger 308and/or other mechanisms for actuating the anastomosis tool 300.

The trigger 308 is connected to a rocker 508. The trigger 308 may beformed into the rocker 508, or otherwise connected to it. The rocker 508is located inside the handle 302. Alternately, the rocker 508 is locatedat least partly outside the handle 302. The rocker 508 is rotatablymounted to a rocker axle 510. The rocker axle 510 extends from oneinterior surface of the handle 302, and may extend to a differentinterior surface of the handle 302 to provide additional stiffnessand/or stability to the rocker axle 510. Alternately, the rocker axle510 may connect to the handle 302 in a different way.

The rocker 508 includes a proximal arm 514 extending proximally to therocker axle 510. The proximal arm 514 may be formed into the rocker 508,or otherwise connected to it. The proximal end 516 of the proximal arm514 may be tapered to a curved or rounded surface. Alternately, theproximal end 516 of the proximal arm 514 is shaped differently.Alternately, the entire proximal arm 514 is tapered. The rocker axle 510is located proximal to the trigger 308. As a result, depression of thetrigger 308 causes rotation of the rocker 508 such that the proximal end516 of the proximal arm 514 moves upward. Alternately, the trigger 308and the rocker axle 510 are positioned differently relative to oneanother. The rocker 508 also includes a distal arm 518 extending distalto the trigger 308, where the distal arm 518 has a distal end 520. Thedistal arm 518 may be formed into the rocker 508, or otherwise connectedto it. Referring also to FIG. 71, at least a portion of the distal arm518 may be bifurcated into two or more spaced-apart members 542. A post544 may be located at the distal end of each member 542. At least onepost 544 substantially may take the shape of a cylindrical orrectangular solid. Each post 544 is angled relative to the correspondingmember 542, protruding at least partly inward. This angle may besubstantially ninety degrees, or any other angle. Alternately, at leastone post 544 extends outward from the corresponding member. The posts544 are spaced apart from one another by a distance that is less thanthe distance separating the spaced-apart members 542. Alternately, atleast one post 544 is located at a position on the corresponding member542 other than its distal end. As one example, at least one post 544 maybe positioned a short distance proximal to the distal end of thecorresponding member 542.

Because the rocker axle 510 is located proximal to the trigger 308,depression of the trigger 308 causes the distal end 520 of the distalarm 518 to move downward. Alternately, the arms 514, 518 of the rocker508 are configured to move in another manner when the trigger 308 isdepressed. Alternately, the rocker 508 may be shaped or configureddifferently than described above.

A proximal slider 522 is also included within the handle 302. Theproximal slider 522 includes at least one flange 524 extending laterallyfrom at least one side thereof. Advantageously, a flange 524 extendsfrom each side of the proximal slider 522 for stability. Additionalflanges 524 may be provided, if desired. Ribs 526 are molded, formed,connected or otherwise attached to the inner surface of the handle 302.Two ribs 526 are spaced apart from one another a distance substantiallyequal to the thickness of the corresponding flange 524, such that eachflange 524 is configured to slide therebetween. Each pair of ribs 526substantially constrains the motion of the corresponding flange 524.Where the ribs 526 are substantially linear, and ribs 526 andcorresponding flanges 524 are utilized on opposite sides of the proximalslider 522, the ribs 526 substantially linearly constrain the motion ofthe corresponding flange 524. A spring 546 is connected at one end tothe handle 302, and is connected to or engages the proximal slider 522.The spring 546 is in compression, and thereby biases the proximal slider522 distally. A stop 547 may be connected to or defined in the innersurface of one or more of the handle shell members 502, where the stopor stops 547 are located distal to the proximal slider 522. The stop orstops 547 act to restrain the distal motion of the proximal slider 522,thereby defining a position that is the most distal the proximal slider522 can travel. Alternately, a different or additional mechanism,structure or method may be used to bias the proximal slider 522distally. Alternately, the spring 546 is initially neither in tensionnor compression, but is compressed by the rocker 508 during at least aportion of its travel.

The spring 546 stores energy within itself when it is in tension.Alternately, an energy storage device could be used in lieu of thespring 546. As one example, the energy storage device is a reservoir orcylinder of pressurized gas. Valves, tubing and/or other structure maybe used to route the pressurized gas to desired locations in the handle302 such that the energy stored in the gas is used to bias the proximalslider 522 distally, and/or to perform other actuation functions withinthe handle 302 and/or the tool 300. The gas may be carbon dioxide,nitrogen, a different gas, air, or a combination of gases. As anotherexample, a cylinder or source of vacuum may be used as an energy storagedevice. Valves, tubing and/or other structure may be used to route thevacuum to desired locations in the handle 302 such that the vacuum canbe used to bias the proximal slider 522 distally, and/or to performother actuation functions within the handle 302 and/or the tool 300.That is, compressed gas may be used for controlling the operation of thetool 300 instead of or in addition to providing energy storage. Asanother example, a battery may be used as an energy storage device.Wiring and actuators such as solenoids or motors may be provided withinthe handle 302 such that the stored electrical energy in the battery isused to bias or hold the proximal slider 522 distally, and/or to performother actuation functions within the handle 302 and/or the tool 300.That is, electromagnetic energy may be used for controlling theoperation of the tool 300 instead of or in addition to providing energystorage. Where such an alternate energy storage device is provided, thetrigger 308 may be configured differently, such that actuation of theanastomosis tool 300 may be performed simply by contacting the trigger308 with a finger, or moving the trigger 308 through a more limitedrange of motion. Alternately, the trigger 308 may be omitted altogether,and the anastomosis tool 300 may be actuated remotely by a computer,dedicated control station, handheld computing device, or other device.

A contact feature 528 is defined on the distal surface of the proximalslider 522. Alternately, the contact feature 528 is a separate elementconnected to the proximal slider 522. The contact feature 528 isconfigured to engage the proximal end 516 of the proximal arm 514 at orafter the time the trigger 308 is depressed, as described in greaterdetail below. The contact feature 528 is angled proximally and downwardalong a lower portion 530 thereof, and is substantially vertical alongan upper portion 532 thereof. Alternately, the contact feature 528 isshaped and/or angled differently.

The first cable or cables 480 are connected to the proximal slider 522in any appropriate way. As an example, at least one aperture or port(not shown) may be formed in the proximal slider 522, and at least onecable 480 is inserted into at least one aperture and secured thereto. Asother examples, an end of the cable or cables 480 may be wound aroundall of or a portion of, crimped to, welded to, or secured by adhesive tothe proximal slider 522. The proximal arm 514 of the rocker 508 may bebifurcated to allow the first cable or cables 480 to extendsubstantially along the longitudinal centerline of the handle 302 andbetween the bifurcations substantially without interference. Similarly,the lower portion 530 of the contact feature 528 may be bifurcated aswell. Where both the proximal arm 514 and the contact feature 528 arebifurcated, the two are aligned such that they contact one anotherduring at least a portion of the travel of the rocker 508.

A distal slider 534 is also included within the handle 302. The distalslider 534 includes a flange 536 extending outward from at least oneside thereof. Advantageously, a flange 536 extends from each side of thedistal slider 534 for stability. Additional flanges 536 may be provided,if desired. Ribs 538 are molded, formed, connected or otherwise attachedto the inner surface of the handle 302. Two ribs 538 are spaced apartfrom one another a distance substantially equal to the thickness of thecorresponding flange 536, such that each flange 536 is configured toslide therebetween. Each pair of ribs 538 substantially constrains themotion of the corresponding flange 536. Where the ribs 538 aresubstantially linear, and ribs 538 and corresponding flanges 536 areutilized on opposite sides of the distal slider 534, the ribs 538substantially linearly constrain the motion of the corresponding flange524.

A contact surface 548 is defined on at least a portion of the proximalsurface of the distal slider 534. The contact surface 548 may be curvedor angled. As one example, the contact surface 548 has a concavecurvature. Other shapes or configurations of the contact surface 548 maybe utilized. Alternately, the contact surface 548 is located on aportion of the distal slider 534 other than its proximal surface. Thedistal slider 534 may include a passage 550 through it to allow thecables 480, 490 to pass therethrough. Alternately, the passage 550 isnot provided in the distal slider 534, and the distal slider 534 isbifurcated or otherwise shaped to allow the cables 480, 490 to passthrough it. Alternately, the cables 480, 490 are routed through thehandle in such a way as to bypass the distal slider 534 altogether.

The distal slider 534 may include a lower guide 552. The lower guide 552extends downward from the remainder of the distal slider 534, and mayextend proximal to the contact surface 548. Further, the lower guide 552may be thinner than the remainder of the distal slider 534. Alternately,the lower guide 552 is not included in the distal slider 534, or may beconfigured differently relative to the remainder of the distal slider534. Optionally, the lower guide 552 may include a flange 554 extendingoutward from at least one side thereof. Advantageously, a flange 554extends from each side of the lower guide 552 for stability. Additionalflanges 554 may be provided, if desired. These flanges 554 provideadditional stability to the distal slider 534. Ribs 556 are molded,formed, connected or otherwise attached to the inner surface of thehandle 302. Two ribs 556 are spaced apart from one another a distancesubstantially equal to the thickness of the corresponding flange 554,such that each flange 554 is configured to slide therebetween. Each pairof ribs 556 substantially constrains the motion of the correspondingflange 554. Where the ribs 556 are substantially linear, and ribs 556and corresponding flanges 554 are utilized on opposite sides of thedistal slider 534, the ribs 556 substantially linearly constrain themotion of the corresponding flange 554.

A spring 540 is connected at one end to the distal slider 534 and at theother end to the handle 302. An aperture 558 may be provided in thelower guide 552, or in another part of the distal slider 534. One end ofthe spring 540 includes a hook or similar structure, which is receivedinto and held by the aperture 558. Alternately, the spring 540 isconnected to the distal slider 534 in a different way. The spring 540 isin tension, and thereby biases the distal slider 534 proximally.Alternately, a different or additional mechanism, structure or methodmay be used to bias the distal slider 534 proximally. The spring 540stores energy within itself when it is in tension. Alternately, anenergy storage device such as a reservoir or container of pressurizedgas, a battery, or other energy storage device such as described abovewith regard to the spring 546 could be used in lieu of the spring 540.

Referring also to FIG. 78, a holder 594 is connected to the innersurface of the handle 302. This connection may be accomplished in anyappropriate manner. As one example, a slot 602 may be defined in amember 604 or between two separate members 604 extending inward from theinner surface of each shell member 502, wherein a portion of the holder594 is held by the slot 602 such as by a pressure fit. The distal end595 of the holder 594 is held by the slot 602 such that it does notsubstantially move. Alternately, a different part of the holder 594 isheld by the slot 602, and/or the distal end 595 of the holder 594 isfree to move. Moving proximally from the distal end 595 of the holder594, the holder 594 is bifurcated by an opening 598 that extendssubstantially longitudinally. Two spaced-apart members 600 extendsubstantially proximally, each member 600 on an opposite side of theopening 598. At least the members 600 of the holder 594 have someflexibility, such that the members 600 can move up or down in responseto force applied to them. However, the members 600 are stiff enough toremain in a neutral position until that force is applied.

A stop 596 extends upward from each member 600. The stops 596 arepositioned and shaped to engage the bottom edge 570 of the contactsurface 548 of the distal slider 534. The holder 594 is substantiallyrestrained against longitudinal motion by its engagement with the slots602 in the shell members 502 and/or members 604 defined in or on theshell members 502. Thus, by engaging the bottom edge 570 of the contactsurface 548 of the distal slider 534, the stops 596 substantiallyrestrain the distal slider 534 against proximal motion under theinfluence of the spring 540. The stops 596 are stiff enough, and extendupward enough, to provide this restraint. For example, the stops 596 maybe curved to match the curvature of the contact surface 548, such thatthey contact a portion of the contact surface. Alternately, contactbetween the distal slider 534 and the rocker 508 prevents the distalslider 534 from substantially moving proximally. This contact occursbetween the contact surface 548 of the distal slider 534 and the distaltip 520 of the distal arm 518 of the rocker 508. Alternately, thiscontact occurs between other or additional components of the distalslider 534 and/or the rocker 508.

The second cable 490 is connected to the distal slider 534 in anyappropriate way. As an example, at least one aperture or port (notshown) may be formed in the distal slider 534, and at least one cable480 is inserted into at least one aperture and secured thereto. As otherexamples, an end of the cable or cables 480 may be wound around all ofor a portion of, crimped to, welded to, or secured by adhesive to thedistal slider 534. The second cable 490 may have an amount of slack init when the distal slider 534 is in the first, predeployment positionshown in FIG. 70. The amount of slack, if any, is related to thedistance traveled by the distal slider 534 during actuation, asdescribed in greater detail below.

Optionally, the distal slider 534 includes a verification stub 560. Theverification stub 560 extends substantially upward from the upper end ofthe distal slider 534. Alternately, the verification stub 560 extendsfrom a different portion of the distal slider 534, or in a differentdirection. The verification stub 560 may extend into or through a slot562 through the handle 302. Because it is connected to the distal slider534, the verification stub 560 moves along the slot 562 in the handle302 when the distal slider 534 moves during operation, as describedbelow. As a result, the position of the verification stub 560 may beused to confirm visually whether a particular anastomosis tool 300 hasbeen actuated or not. That is, the verification stub 560 may be locatedin a first position before the anastomosis tool 300 is actuated, and ina second position after the anastomosis tool 300 is actuated, such thatthe user can determine whether the anastomosis tool 300 has beenactuated by viewing the position of the verification stub 560.

Optionally, the rocker 508 includes a ratchet 564 extendingsubstantially downward from a location distal to the rocker axle 510.Alternately, the ratchet 564 extends in a different direction. Theratchet 564 includes a member 566 at its lower end extendingsubstantially transverse to the remainder of the ratchet 564.Alternately, the member 566 extends in a different direction.Alternately, the member 566 is a notch or other element defined in theratchet 564. The ratchet 564 moves in conjunction with the rocker 508.Thus, when the trigger 308 is depressed and the distal end of the rocker508 moves downward, the ratchet 564 moves downward as well. A pawlfeature 568 is configured to engage the member 566 of the ratchet 564after the ratchet 564 has moved downward a particular distance, allowingthe ratchet 564 to continue to move downward after engagement, butpreventing the ratchet 564 from moving back upward past the pawl feature568 after engagement.

Fluid-Driven Actuator

Alternately, the rocker 508, sliders 522, 534, and/or other mechanismsin the handle 302 are not used, and a different mechanism or mechanismsare used to actuate the tissue effector 400 and complete theanastomosis. For example, a fluid-driven actuator may be used, where acontainer of gas within the handle 302 or a connection to a tank,reservoir or other storage device outside the handle 302 provides gasunder pressure to a switching assembly or other mechanism. The switchingassembly utilizes and/or directs the pressure of the gas to successivelyactuate the components of the tissue effector 400. Vacuum or liquid maybe used instead of gas, if desired. As another example, the handle 302may include an electromechanical assembly under analog or digitalcontrol, such that actuation of the trigger 308 or other componentcauses actuation of the tissue effector.

The fluid-driven actuator may be any mechanism that is configured tooperate the tissue effector 400. Such operation may include moving thetissue effector 400 from the open to the closed position, moving thetissue effector 400 from the closed to the open position, and/ordeploying connectors from the tissue effector 400.

Fluid-Driven Actuator—Control Member

Referring to FIGS. 148-149, a handle 302 of the anastomosis tool 300 mayinclude an exemplary fluid-driven actuator 1000. The fluid-drivenactuator 1000 includes a control member 1002 movable within a firstchamber 1004. Referring also to FIG. 152, the control member 1002 isoperationally connected to the trigger 308, as described in greaterdetail below. The control member 1002 may be generally rod-shaped, andthe first chamber 1004 may be generally cylindrical. Alternately, thecontrol member 1002 and/or the first chamber 1004 may be shapeddifferently. At least one sealing element 1006 extends from the controlmember 1002. Each sealing element 1006 may be an O-ring or any othersuitable structure or mechanism that substantially seals against thecontrol member 1002 and the wall of the first chamber 1004. Each sealingelement 1006 may be connected to the control member 1002 in any suitablemanner. As one example, where the sealing element 1006 is an O-ring, thesealing element 1006 may be friction-fit or pressure-fit to the controlmember 1002. As another example, the diameter and/or cross-section ofthe control member 1002 may be reduced at the interface of the controlmember 1002 and at least one sealing element 1006, forming anindentation into which the sealing element 1006 may be seated securely.

At least one rib 1008 may extend from the control member 1002 adjacentto at least one sealing element 1006. Each rib 1008 may be integralwith, or may be a separate element fixed to, the control member 1002.Advantageously, one rib 1008 extends from the control member 1002 oneither side of at least one sealing element 1006. Thus, the two ribs1008 substantially trap the corresponding sealing element 1006therebetween, substantially restraining the sealing element 1006 fromsliding or otherwise moving relative to the control member 1002 duringmotion of the control member 1002. At least one outer edge 1007 of atleast one rib 1008 may be beveled, curved or similarly shaped.Advantageously, the ribs 1008 do not extend far enough from the sealingelement 1006 to contact the wall of the first chamber 1004. Thus, asubstantially ring-shaped passage exists between each rib 1008 and thewall of the first chamber 1004, allowing gas to travel through thatpassage as described in greater detail below. Alternately, at least partof at least one rib 1008 may contact the wall of the first chamber 1004.If so, the part of each rib 1008 that contacts the wall of the firstchamber 1004, and/or the wall of the first chamber 1004, advantageouslymay be coated with polytetrafluoroethylene or other lubricious coatingor substance to facilitate motion of each rib 1008 that contacts thewall of the first chamber 1004.

A biasing element 1009 such as a spring is connected to the controlmember 1002, to the wall of the first chamber 1004, and/or to the bodyof the handle 302. The biasing element 1009 biases the control member1002 to a first position within the first chamber 1004, as shown in FIG.149. The distal end of the control member 1002 may extend out of thedistal end of the first chamber 1004 when the control member 1002 is inthe first position. The part of the control member 1002 that extends outof an end of the first chamber 1004 advantageously remains within thebody of the handle 302.

One or more tabs 1014 may extend outward from the control member 1002 ata location on the control member 1002 outside the first chamber 1004. Atleast one tab 1014 may have two opposed ends, one of which is connectedto the control member 1002, and the other of which is free. The free endof each tab 1014 may be oriented at least partially in the proximaldirection. The tabs 1014 extend from the control member 1002 asufficient distance such that they do not enter the first chamber 1004when movement of the control member 1002 moves the tabs 1014 toward thefirst chamber 1004. Instead, the tabs 1014 contact a surface 1016 of abody 1018 in which the first chamber 1004 is defined, thereby stoppingmotion of the control member 1002. In this way, the control member 1002may be moved from a first position to a second position. At least one ofthe first position and the second position of the control member 1002may be defined within a range of locations in the first chamber 1004.The free ends of the tabs 1014 include ramp surfaces 1015 that engagethe end of the first chamber 1004. Upon application of greater force tothe control member 1002, the ramp surfaces 1015 of the tabs 1014 arepressed inward toward the longitudinal axis of the control member 1002as a result of contact between the ramp surfaces 1015 and the end of thefirst chamber 1004. After the tabs 1014 have moved inward a sufficientamount, the control member 1002 is free to move along the first chamber1004 until its end opposite the tabs 1014 contacts the corresponding endof the first chamber 1004. This contact stops the motion of the controlmember 1002 at a defined third position. Alternately, the tabs 1014 arenot movable into the first chamber 1004.

Referring also to FIGS. 148 and 152, a slot 1017 may be defined in theend of the control member 1002 that extends out of the first chamber1004. The slot 1017 is configured to receive a transverse member 1032connected to the trigger 308. The transverse member 1032 may be orientedsubstantially perpendicular to the longitudinal axis of the controlmember 1002. Alternately, the transverse member 1032 is orienteddifferently relative to the longitudinal axis of the control member1002. The trigger 308 also may include one or more projections 1034 eachconfigured to engage a corresponding depression or other receiver (notshown) in the inner surface of a casing 1071 of the handle 302 or astructure or mechanism associated with the handle 302. The trigger 308thus rotates about the axis defined by the one or more projections 1034.The transverse member 1032 is positioned between the surface of thetrigger 308 depressed by the surgeon and the axis of rotation defined bythe one or more projections 1034. As a result, rotation of the trigger308 about its axis of rotation causes the transverse member 1032 totravel in an arc. As shown in FIG. 152, that arc may be directedproximally. Motion of the transverse member 1032 in an arc in theproximal direction pushes the control member 1002 proximally, as aresult of contact between the transverse member 1032 and the slot 1017in the control member 1002. Alternately, the trigger 308 and/or thecontrol member 1002 are configured in a different manner that convertsthe actuation of the trigger 308 to motion of the control member 1002.

Fluid-Driven Actuator—Clamping Member

Referring also to FIG. 149, the exemplary fluid-driven actuator 1000also includes a clamping member 1010 movable within a second chamber1012. Referring also to FIG. 148, the distal end of the clamping member1010 is connected to the first cable 480 in any suitable manner. As oneexample, the distal end of the clamping member 1010 extends out of thedistal end of the second chamber 1012, and includes a hook 1020 definedtherein or connected thereto. A segment of the first cable 480 near theproximal end thereof is placed into the hook 1020, and may be woundrepeatedly about the hook 1020 if desired. The proximal end of the firstcable 480 is oriented distally, and is substantially parallel to aremaining segment of the first cable 480. A crimp 1022 compresses theproximal end of the first cable 480 against a remaining segment of thefirst cable 480, securing the proximal end of the first cable 480 to aremainder of itself, and thereby securing the first cable 480 to thehook 1020. Alternately, the first cable 480 may be connected to theclamping member 1010 by a ferrule, by tying, adhesive, winding, or inany other suitable manner.

The clamping member 1010 may be generally rod-shaped, and the secondchamber 1012 may be generally cylindrical. The second chamber 1012 mayhave a first diameter at a distal part thereof, and a second, largerdiameter at a proximal part thereof. Alternately, the clamping member1010 and/or the second chamber 1012 may be shaped differently. At leastone sealing element 1006 extends from the clamping member 1010. Thesealing element or elements 1006, and their attachment to the clampingmember 1010, may be as described above with regard to the control member1002. At least one rib 1008 may extend from the clamping member 1010adjacent to at least one sealing element 1006, as described above withregard to the control member 1002. At least one rib 1008 may be locatedin the wider portion of the second chamber 1012. When the clampingmember 1010 is in a first position, as shown in FIG. 149, that rib 1008may be positioned at the distal end of the wider portion of the secondchamber 1012, against a ledge 1024 defined in the second chamber 1012 bythe reduction in diameter of the second chamber 1012 in the distaldirection. Contact between that rib 1008 and the ledge 1024 restrainsthe clamping member 1010 from motion distal to its first position. Theclamping member 1010 may be biased to the first position by tension inthe first cable 480, which acts to pull the clamping member 1010distally such that the rib 1008 in the wider portion of the secondchamber 1012 is brought into contact with the ledge 1024.

Fluid-Driven Actuator—Firing Member

The fluid-driven actuator 1000 also includes a firing member 1026movable within a third chamber 1028. Referring also to FIG. 148, thedistal end of the firing member 1026 is connected to the second cable490 in any suitable manner. As one example, the distal end of the firingmember 1026 extends out of the distal end of the third chamber 1028, andincludes a hook 1020 defined therein or connected thereto. The secondcable 490 may be connected to the hook 1020 of the firing member 1026 insubstantially the same manner as described above with regard to theconnection of the first cable 480 to the hook 1020 of the clampingmember 1010. Alternately, the second cable 490 may be connected to thefiring member 1026 in any suitable member, whether or not the firingmember 1026 includes a hook 1020. The second cable 490 is also connectedto the sled 482, directly or indirectly.

The firing member 1026 may be generally rod-shaped, and the thirdchamber 1028 may be generally cylindrical. The third chamber 1028 mayhave a first diameter at a distal part thereof, and a second, largerdiameter at a proximal part thereof. Alternately, the firing member 1026and/or the third chamber 1028 may be shaped differently. At least onesealing element 1006 extends from the firing member 1026. The sealingelement or elements 1006, and their attachment to the firing member1026, may be as described above with regard to the control member 1002.At least one rib 1008 may extend from the firing member 1026 adjacent toat least one sealing element 1006, as described above with regard to thecontrol member 1002. At least one rib 1008 may be located in the widerportion of the third chamber 1028. When the firing member 1026 is in afirst position, as shown in FIG. 149, that rib 1008 may be positioned atthe distal end of the wider portion of the third chamber 1028, against aledge 1030 defined in the third chamber 1028 by the reduction indiameter of the third chamber 1028 in the distal direction. Contactbetween that rib 1008 and the ledge 1030 restrains the firing member1026 from motion distal to its first position. The firing member 1026may be biased to the first position by tension in the second cable 490,which acts to pull the firing member 1026 distally such that the rib1008 in the wider portion of the third chamber 1028 is brought intocontact with the ledge 1030.

Fluid-Driven Actuator—Passages

A gas inlet 1036 opens into the first chamber 1004. A gas inlet orifice1038 exists at the intersection of the gas inlet 1036 and the firstchamber 1004. The gas inlet 1036 may receive pressurized gas from, forexample, the cylinder 1046 shown in FIG. 153. A gas outlet 1040 alsoopens into the first chamber 1004. A gas outlet orifice 1042 exists atthe intersection of the gas outlet 1040 and the first chamber 1004. Thegas outlet 1040 may vent gas out of the body 1018 and/or the handle 302.

A plurality of passages interconnect each chamber 1004, 1012, 1028 to atleast one other chamber 1004, 1012, 1028. The passages may besubstantially round in cross-section, or may be shaped in any othersuitable manner. An orifice exists at each connection between a chamber1004, 1012, 1028 and a passage. The location of each orifice in acorresponding chamber 1004, 1012, 1028 is selected in conjunction withthe location of the sealing elements 1006 along the members 1002, 1010,1026 to produce a desired motion of the clamping member 1010 and thefiring member 1026 upon depression of the trigger 308. As described ingreater detail below, the fluid-driven actuator 1000 transitions amongtwo or more discrete states upon the introduction of pressurized gasinto the fluid-driven actuator and the application of force to thetrigger 308 to control the position of the control member 1002.

Fluid-Driven Actuator—Working Fluid

Where the handle 302 includes a fluid-driven actuator 1000, the handle302 is configured to accommodate the working fluid, be it gas or liquid,that is utilized by the fluid-driven actuator 1000. Referring to FIGS.152-153, as one example, the handle 302 may include a cylinder receivingspace 1044 configured to receive a gas cylinder 1046. The gas cylinder1046 may hold pressurized gas of any suitable type, such as carbondioxide, nitrogen or argon. The gas cylinder 1046 is a standardcommercially-available item that holds a suitable volume of gas at adesired pressure. The gas cylinder 1046 includes a neck end 1047configured to be punctured to release gas stored within.

The gas cylinder 1046 is held within the cylinder receiving space 1044by a knob 1048 that is movable relative to the handle 302. The knob 1048may be configured in any suitable manner. As one example, the knob 1048includes a spindle 1049 that has at least one thread 1050 that isreceived in corresponding threads 1052 located on an inner surface of aspindle receiving space 1053 located at the proximal end of the handle302. Rotation of the knob 1048 thus causes the knob 1048 to both rotateand advance. However, the knob 1048 may move in any other suitablemanner relative to the handle 302. For example, the knob 1048 may simplybe slidable. Alternately, the knob 1048 and the spindle receiving space1053 are located at a different position relative to the handle 302. AnO-ring 1045 or other sealing element may be connected to the spindle1049 in any suitable manner. For example, the O-ring 1045 may be held ina notch defined in the spindle 1049, or may be held between threads 1050of the spindle 1049. The O-ring 1045 is sized and positioned to sealsubstantially the cylinder receiving space 1044, such that gassubstantially does not exit the cylinder receiving space 1044 past thespindle 1049. The cylinder receiving space 1044, gas cylinder 1046,spindle 1049, and spindle receiving space 1053 are all substantiallyaligned about their longitudinal axes, which are oriented substantiallyparallel to the longitudinal axis of the handle 302. Alternately, thosecomponents are oriented in a different manner relative to the handle 302and/or to one another. The distal end of the spindle 1049 may be curvedto correspond to the curvature of the proximal end of the gas cylinder1046. Alternately, the distal end of the spindle 1049 may be flat, ormay be shaped in any other suitable manner.

The handle 302 may include at least one stop 1054 that extends into thespindle receiving space 1053. The stop 1054 may include a pin 1056connected to a spring 1058 or other biasing element that biases at leastpart of the pin 1056 into the spindle receiving space 1053. Alternately,the stop 1054 may be any other suitable mechanism or structure, such asa tab or prong that extends into the spindle receiving space 1053without being biased by a spring 1058 or other biasing element.Alternately, the stop 1054 may be omitted. A first notch 1060 in thespindle 1049 engages the stop 1054. Contact between the first notch 1069and the stop 1054 prevents the spindle 1049 from being rotated out ofthe spindle receiving space 1053, and thereby prevents removal of thegas cylinder 1046 from the cylinder receiving space 1044. When the knob1048 is moved toward an activation position, the first notch 1060 doesnot interfere with the resulting motion of the spindle 1049, and thethreads 1050 on the spindle 1049 rotate such that at least part of thestop 1054 is located between adjacent threads on the spindle 1049 duringmotion of the knob 1048. A second notch 1062 may engage the stop 1054after the knob 1048 has been moved to the activation position. Contactbetween the second notch 1062 and the stop 1054 stops the motion of thespindle 1049 when the knob 1048 has been moved to the activationposition. Optionally, the notches 1060, 1062 are opposite ends of agroove defined in the spindle 1049.

A spike 1064 extends into the cylinder receiving space 1044, and issized, shaped and located to contact and puncture the neck end 1047 ofthe gas cylinder 1046. For example, the spike 1064 may be located at thedistal end of the cylinder receiving space 1044, oriented substantiallyin the proximal direction. Alternately, the spike 1064 is located in adifferent location in the cylinder receiving space 1044, and/or isoriented differently. Referring also to FIG. 149, the spike 1064includes an aperture 1066 defined therein. The aperture 1066 is locatedon the spike 1064 at a position that allows gas to flow out of the gascylinder 1046 and into the aperture 1066 after the spike 1064 haspunctured the neck end 1047 of the gas cylinder 1046.

Fluid-Driven Actuator—Pressure Regulation Assembly

Optionally, referring to FIGS. 163-166, the aperture 1066 of the spike1064 may be connected to a pressure regulation assembly 1070. Thepressure regulation assembly 1070 may include a pressure control member1072 positioned within a regulator space 1078 defined in the handle 302.The pressure control member 1072 may be a rod, or may be shaped orconfigured in any other suitable manner. A biasing element 1074 may beconfigured to bias the pressure control member 1072 and the spike 1064toward the gas cylinder 1046. The biasing element 1074 may be anystructure or mechanism that is suitable for biasing the pressure controlmember 1072 distally. As one example, the biasing element 1074 is a coilspring, and at least part of the pressure control member 1072 isreceived within that coil spring. The biasing element 1074 may besubstantially fixed at one end by any suitable structure, mechanism ormethod. As one example, a stop 1076 is fixed to the wall of theregulator space 1078, such as by a friction fit, a pressure fit, or aninterference fit, or by welding or by adhesive. Alternately, an end ofthe biasing element 1074 is directly connected to the wall of theregulator space 1078 or to the body of the handle 302. For example, anend of the biasing element 1074 may be molded into the handle 302.

The pressure control member 1072 may have a smaller cross-section closerto its distal end than to its proximal end. For example, the pressurecontrol member 1072 may be shaped to include a cylinder having a smallerdiameter closer to the proximal end of the pressure control member 1072,and a cylinder having a larger diameter closer to the distal end of thepressure control member 1072. One or more ribs 1008 may extend from thepressure control member 1072, where such ribs 1008 may be configuredsubstantially as described above. Advantageously, one rib 1008 extendsfrom the pressure control member 1072 on either side of at least onesealing element 1006. Thus, the two ribs 1008 substantially trap thecorresponding sealing element 1006 therebetween, substantiallyrestraining the sealing element 1006 from sliding or otherwise movingrelative to the pressure control member 1072 during motion of thepressure control member 1072. One or more sealing elements 1006 mayalso, or instead, be located in an annular groove 1170 define in thepressure control member 1072. Alternately, one or more sealing elements1006 may be connected to the pressure control member 1072 in a differentmanner. The gas inlet 1036 is a passage is connected to the regulatorspace 1078. An orifice O14 exists in the wall of the regulator space1078 at the intersection between the gas inlet 1036 and the regulatorspace 1078. A passage P7 operationally connects the aperture 1066 of thespike 1064 to the regulator space 1078. An orifice O15 exists in thewall of the regulator space 1078 at the intersection between the passageP7 and the regulator space 1078.

The knob 1048 may be rotatable or otherwise movable between twopositions. Initially, the knob 1048 is in a neutral position thatsubstantially does not exert force on the gas cylinder 1046. The knob1048 is rotatable or otherwise movable to an activation position, inwhich the spindle 1049 exerts a force on the gas cylinder 1046, pressingit into contact with the spike 1064. When the knob 1048 is in theactivation position, the spike 1064 has punctured the neck end of thegas cylinder 1046. Optionally, the knob 1048 includes an indicator 1080,such as a substantially planar tab extending from the proximal end ofthe knob 1048. When the indicator 1080 is in a particular position, itprovides positive confirmation that the gas cylinder 1046 has beenpunctured. The indicator 1080 may be configured in any suitable manner.As one example, where the indicator is a substantially planar tab, itsorientation relative to the handle 302 and/or a marker on the handle 302confirms that the knob 1048 is in the activation position and that thegas cylinder 1046 has been punctured by the spike 1064.

Alternately, the gas cylinder 1046 is not used; instead, gas is storedin a reservoir (not shown) defined within the handle 302. Where the gascylinder 1046 is not used, the spike 1064, the cylinder receiving space1044, and other components utilized to hold and/or control the gascylinder 1046 and the gas flow therefrom need not be provided. Rather,upon activating the knob 1048, gas is released from the reservoir intothe gas inlet 1036. Any suitable mechanism for regulating the pressureat the gas inlet 1036 may be utilized. Alternately, the gas cylinder1046 is not used, and the handle 302 or other part of the anastomosistool 300 receives pressurized gas from a source outside the handle 302.Such an energy source located outside the tool may be characterized asan external utility. Examples of an external utility include apressurized gas feed provided at a wall outlet or on a portable gassupply. The external utility may be connected to the gas inlet 1036 ofthe handle 302 in any suitable manner, such as via a hose or othersuitable connecting structure or mechanism. The pressure may beregulated at the source outside the handle 302, such that pressureregulation need not be provided within the anastomosis tool 300.

Graft Vessel Preparation

The graft vessel 404 is harvested from the patient in a conventionalmanner. The graft vessel 404 may be a saphenous vein, radial artery,mammary artery, or any other appropriate blood vessel. Alternately, thegraft vessel 404 may be harvested from a different person or from acadaver. Alternately, a xenograft or an artificial graft vessel may beprovided.

Graft Vessel Preparation—Retractor Mount

The graft vessel 404 can be prepared in any appropriate manner foranastomosis to a target vessel. As one example, a system including oneor more preparation tools may be used to prepare the graft vessel foranastomosis. Referring to FIGS. 79-80A, a retractor mount 620 is shown.The retractor mount 620 is detachably connected to a standard surgicalretractor 750 used for an open-chest surgical procedure. The retractormount 620 may include a first clamp element 622 and a second clampelement 624, which are movable relative to one another. As one example,the clamp elements 622, 624 are slidable relative to one another. Thefirst clamp element 622 includes a first engagement feature 626 at itsdistal end, and the second clamp element 624 includes a secondengagement feature 628 at its distal end. The first engagement feature626 is located distal to the second engagement feature 628. Theengagement features 626, 628 are configured to engage the retractor 750,such as by clamping onto at least a portion of that retractor 750. Thatclamping may result from biasing the engagement features 626, 628 towardone another. Such bias may be provided by one or more compressionsprings 630 positioned relative to the clamp elements 622, 624. Forexample, the first clamp element 622 may include a first wall 632 andthe second clamp element 624 may include a second wall 634 proximal tothe first wall 632, between which at least one spring 630 is positioned.The spring or springs 630 act in compression to push the engagementfeatures 626, 628 toward one another. The engagement features 626, 628are moved apart by applying a force opposite to the bias provided by thespring or springs 630, thereby moving the engagement features 626, 628away from one another. When that force is removed, the engagementfeatures 626, 628 move closer to one another, such as to clamp onto theretractor 750.

The retractor mount 620 may include a post 636 connected at one end to awasher 638 or other structure and at the other end to an actuator 640.The actuator 640 is shaped and finished to be grasped and rotated by auser. The actuator 640 is configured to compress the clamp elements 622,624 together in order to hold them in a selected position. Suchcompression substantially prevents relative motion of the clamp elements622, 624 by increasing the friction between them to an amount greaterthan the biasing force. For example, the actuator 640 may be actuated torestrain the clamp elements 622, 624 to facilitate positive engagementbetween the retractor mount 620 and the retractor 750. The compressionexerted by the actuator 640 may be in a direction substantiallyperpendicular to the direction of translation of the clamp elements 622,624 relative to one another. The actuator 640 may apply compression inany appropriate manner. As one example, the first clamp element 622includes a longitudinal slot 642 that allows it to translate relative tothe post 636. The actuator 640 may include a ledge 644 protruding fromits underside 646 that is sized and shaped to extend only into the slot642. The distance that the ledge 644 extends below the underside 646 isselected such that the clamp elements 622, 624 can slide freely relativeto one another when the ledge 644 is positioned in the slot 642. Whenthe actuator 640 is rotated about the post 636, the ledge 644 comes outof the slot 642 and presses down the first clamp element 622,compressing it against the second clamp element 624. The ledge 644 andslot 642 are shaped and finished such that the ledge 644 can come out ofthe slot 642 upon application of force to the actuator 640. Optionally,a surface of at least one clamp element 622, 624 and/or the actuator 640is configured to include at least one gripping feature (not shown). Thegripping feature or features are located to assist in holding the clampelements 622, 624 together when the retractor mount 620 clamps theretractor 750. Such gripping features may include raised areas, areas ofincreased surface roughness, or other features. If one or more grippingfeatures are used, the actuator 640 may exert less compression on theclamp elements 622, 624 to hold them together than if the grippingfeatures were not present. Further, the actuator 640 may be omittedaltogether if the gripping features provide sufficient resistance tomotion between the clamp elements 622, 624 when the retractor mount 620clamps the retractor 750. Alternately, the retractor mount 620 may bepermanently connected to, or constructed as an integral part of, asurgical retractor.

The retractor mount 620 may include a holder 648. The holder 648 may bemoveable relative to another portion of the retractor mount 620. Forexample, the holder 648 may be rotatable relative to another portion ofthe retractor 620. The holder 648 includes a clip 650 configured toengage an anastomosis tool 300 and/or another component of the systemfor preparing the graft vessel for anastomosis. The holder 648 alsoincludes a base 652 connected to the clip 650. The holder 650 may bemoveable among two or more discrete positions, or may move smoothlythrough a range of positions. As one example, the base 652 is adisc-shaped element, and the holder 648 is rotatable among two or morediscrete positions. The base 652 is positioned on or adjacent to asurface 654 of the first clamp element 622. The surface 654 is orientedto place tools held by the holder 648 in a useful orientation relativeto the patient. Alternately, the base 652 is positioned on the secondclamp element 624 or a different portion of the retractor mount 620. Aspindle 656 extends from the base 652 into a tube 658 extending into orthrough the surface 654 of the first clamp element 622. Where thespindle 656 extends all the way through the tube 658, at least oneflange 660 extends laterally from the spindle 656 to hold the spindle656 in the tube 658 and prevent it from sliding out.

The surface 654 includes two or more troughs 658 defined therein. Thetroughs 658 are substantially linear, and substantially parallel to oneanother. Alternately, the troughs 658 may be oriented differently. Atleast one stub 662 extends downward from the base 652. Each stub 662 issized and shaped to engage a trough 658 in the surface 654. Suchengagement substantially prevents free rotation of the holder 648relative to the surface 654. The base 652 is held against the surface654, and therefore the stub or stubs 662, are each held against acorresponding trough 658, with a force related to the length andrigidity of the spindle 656. The flange 660 prevents gross upward motionof the spindle 656 and therefore the holder 648, such that the holder648 is capable of limited motion perpendicular to the surface 654 atleast partially as a result of flexibility of the spindle 656. The depthof each trough 658, and the distance that each stub 662 extends downwardfrom the base 652 into the corresponding trough 658, act to hold thebase 652 in the selected position. Correspondingly, the depth of eachtrough 658 and the distance that each stub 662 extends downward from thebase 652 is related to the force required to remove that stub 662 fromengagement with the trough 658 and cause the base 652 to rotate. Eachstub 662 is shaped, and the cross-section of each trough 658 is shaped,to allow the stub 662 to move out of the trough 658 upon the applicationof force about the longitudinal axis of the spindle 656. The amount offorce is selected to be low enough to allow the holder 648 to be rotatedby hand, but high enough to allow the holder 648 to maintain a selectedposition in use. The number of troughs 658 determines the number ofdiscrete positions to which the base 652 can be rotated. Advantageously,two or more stubs 662 extend from the edge of the base 652. Alternately,other structures or mechanisms are provided to allow the base 652 torotate and maintain a selected position relative to the surface 654. Theclip 650 of the holder 648 may be fixed to the base 652, such that theclip 650 rotates or otherwise moves along with the base 652. Thus, atool or other object held by the clip 650 rotates or otherwise movesalong with the base 652. Alternately, the holder 648 and the surface 654are configured to allow substantially continuous rotational motion ofthe holder 648 relative to the surface 654. In such a configuration, thetroughs 658 on the surface 654 and the stub or stubs 662 on the holder648 may be omitted. As an example of such a configuration, a spring (notshown) is connected at one end to the base 652 of the holder 648 and atthe other end to the tube 658, where the spring is configured to pullthe base 652 into contact with the surface 654. The amount of forceexerted by the spring is large enough to hold the base 652 substantiallyagainst the surface 654 at any selected rotational orientation, and issmall enough to allow for rotation of the holder 648 relative to thesurface 654 upon application of a reasonable amount of rotational forceby the operator. As another example of such a configuration, frictionalforce between the base 652 and the surface 654 is sufficient to hold thebase 652 in a selected rotational orientation. Such frictional force mayresult from the surface finish of the base 652 and/or the surface 654.

Graft Vessel Preparation—Transfer Clamp Assembly

Referring to FIGS. 81-82A, a transfer clamp assembly 670 is another toolthat may be used in the preparation of a graft vessel for anastomosis.The transfer clamp assembly 670 includes a transfer clamp 672 connectedto an extension arm 674. The extension arm 674 may be detachablyconnected to or permanently fixed to the transfer clamp 672. Optionally,the extension arm 674 may be omitted. The transfer clamp assembly 670 isconnectable to the retractor mount 620. For example, the extension arm674 and clip 650 may be configured such that the extension arm 674 snapsinto the clip 650 and is held securely by it. The extension arm 674 maybe detachably connected to the holder 648 or other portion of theretractor mount 620. Alternately, the extension arm 674 is omitted, andthe transfer clamp 672 itself is connected to the holder 648 or otherportion of the retractor mount 620. Alternately, the transfer clampassembly 670 is permanently connected to the retractor mount 620. Theextension arm 674 is configured to connect to the holder 648 and holdthe transfer clamp 672 is a position in proximity to the site where ananastomosis is performed. Such proximity may be desirable where thegraft vessel is a mammary artery, or where the anastomosis is to beperformed after a proximal anastomosis at one end of the graft vessel.

Optionally, a poke-through tip 678 is connected to the extension arm 674in any appropriate manner. As one example, the poke-through tip 678includes a tubular or hollow sleeve 680 at its proximal end, where thesleeve 680 is configured to fit over a portion of an end of theextension arm 674. The poke-through tip 678 may be connected to theextension arm 674 in any appropriate manner. As one example, theextension arm 674 has an annular depression (not shown) defined therein,and the poke-through top 678 includes an annular ridge (not shown)defined therein, such that the annular ridge can be received in theannular depression to mechanically hold the poke-through tip 678 ontothe extension arm 674. As another example, friction between the sleeve680 and the extension arm 674 holds the poke-through tip 678 in place.As another example, an adhesive or other substance, mechanism and/orstructure may be used in conjunction with the sleeve 680, or without thesleeve 680, to secure the poke-through tip 678 to the extension arm 674.As another example, the poke-through tip 678 is formed into theextension arm 674. The poke-through tip 678 may be positioned at thefree end of the extension arm 674. Alternately, the poke-through tip ispositioned at a different location on the extension arm 674. Thepoke-through tip 678 may be made of a thermoplastic elastomer, such asthe C-FLEX® brand thermoplastic elastomer of Consolidated PolymerTechnologies, Inc., a polymer, a plastic, or any other soft, durablematerial. Alternately, the poke-through tip 678 is substantially rigid.The rigid poke-through tip 678 may be tubular, or have a differentshape. The poke-through tip 678 has at least one dimension greater thanthe length of the longest spike 410, to prevent interference betweenthem. Alternately, a poke-through tip 678 is connected to a separatetool, such as a dedicated poke-through tool.

Referring to FIGS. 81-85, the transfer clamp 672 includes two arms 682extending distally from a base 684. The arms 682 are substantiallyparallel to one another. Alternately, the arms 682 may be orienteddifferently relative to one another. The arms 682 are biased to a closedposition, and may be moved apart to an open position. One of the arms682 may be formed into the base 684 or otherwise fixed to the base 684,while the other arm 682 may be movable relative to the base 684 andbiased toward the fixed arm 682. However, both arms 682 may be moveablerelative to the base 684. Each movable arm 682 is configured totranslate laterally relative to the base 684. The arms 682 are sized,shaped and spaced relative to one another such that a portion of ananastomosis tool can be received onto the arms 682 when they are in theopen position, as described in greater detail below.

The base 684 may include a channel 686 defined laterally therein. Atleast one arm 682 may be connected to or include a corresponding runner688 sized and shaped to translate within the channel 686. Theinteraction between the runner 688 and the channel 686 guides thetranslation of the runner 688, and thus the translation of the arm 682connected to the runner 688. The channel 686 and runner 688 may beconfigured in any appropriate manner. As one example, the channel 686and the runner 688 are both substantially cylindrical, and the diameterof the runner 688 is slightly less than the diameter of the channel 686.The base 684 includes an opening into the channel 686 to allow therunner 688 to connect to the remainder of the arm 682 and slide relativeto the channel 686.

The arms 682 may be biased to a closed position with a spring 694.Advantageously, the spring 694 is a coil spring, but may be a leafspring or other type of spring. One end of the spring 694 is fixedrelative to the base 684, and the other end of the spring 694 isconnected to a portion of the movable arm 682, such as the runner 688.The spring 694 is connected to the base 684 and the movable arm 682 suchthat the arms 682 are biased to the closed position and the user mustovercome the biasing force of the spring 694 to increase the distancebetween the arms 682. The spring 694 may be positioned within thechannel 686, or at a different location in the transfer clamp 672. Thespring 694 may be connected to the arm 682 and/or base 684 by molding aportion of it into the corresponding component, securing an end of thespring 694 to a stub 696, or utilizing any other appropriate structure,mechanism or method. Alternately, the spring 694 is simply trappedwithin the channel 686 without being positively connected to the arm 682and/or base 684. Where the spring 694 is a coil spring, its axialcenterline is substantially collinear with the axial centerline of thechannel 686. Alternately, two or more springs 694 may be used instead ofa single spring, if desired.

At least one arm 682 may include a registration pin 690 or otherregistration feature, and the corresponding arm 682 may include aregistration aperture 692 or other corresponding registration feature.The registration pin 690 is substantially parallel to and spaced apartfrom the channel 686. When the arms 682 are in the open position, theregistration pin 690 is outside of the registration aperture 692. As thedistance between the arms 682 decreases, the registration pin 690 isreceived into the registration aperture 692 of the other arm 682 andslides relative to the registration aperture 692. Because the motion ofthe arm 682 is constrained by both the registration pin 690 and thechannel 686, the arms 682 are aligned, and remain in a desiredorientation relative to one another. That is, the simultaneous linearmotion of the registration pin 690 along the registration aperture 692and the runner 688 along the channel 686 constrains the arms 682 to aplane. Alternately, at least a portion of the registration pin 690remains within the corresponding registration aperture 692 at all timesduring motion of the arm or arms 682.

Optionally, at least one finger pad 698 is connected to the base 684and/or at least one arm 682. The finger pads 698 may be substantiallycentered relative to the longitudinal centerline of the channel 686 inthe base 684. As a user compresses the finger pads 698 toward oneanother, a longitudinal force is exerted on and compresses the spring696, and the runner 688 translates within the channel 686, increasingthe distance between the arms 682. The finger pads 698 may be shaped inany appropriate manner. Further, one or more of the finger pads 698 maybe formed integrally with the corresponding base 684 or arm 682, ifdesired. Advantageously, the finger pads 698 are spaced apart a distancesuch that they can be operated by the user with a single hand, such asby pressing the finger pads 698 with the thumb and forefinger.

Each arm 682 includes at least one jaw 700. The jaws 700 on differentarms are opposed to one another, such that a jaw 700 on one arm 682faces a corresponding jaw 700 on the other arm 682. At least one jaw 700may extend laterally away from the corresponding arm 682 toward theother arm 682. Further, the jaws 700 may instead or additionally extendin a direction perpendicular to the arms 682, above a plane defined bythe longitudinal centerlines of the arms 682.

Optionally, at least one set of corresponding jaws 700 each includes ashim 702 extending upward from a remainder of the jaw 700 to provide amore secure grip for a graft vessel, as described in greater detailbelow. Each corresponding shim 702 is sized and shaped in substantiallythe same manner. For example, each corresponding shim 702 may besubstantially rectangular. However, the shims 702 may be shapeddifferently, if desired.

Each jaw 700 is formed into or otherwise fixed to the corresponding arm682. Alternately, at least one jaw 700 is movable relative to thecorresponding arm 682, in which case the corresponding arm 682 may befixed relative to the base 684. Optionally, at least one jaw 700includes a gripping surface 704 defined thereon or connected thereto.The gripping surface 704 may be any surface finish, treatment, elementor other structure, mechanism or feature to facilitate gripping a graftvessel between corresponding jaws 700. As one example, each grippingsurface 704 includes a number of raised elements defined therein,alternating with depressions or other surface. As another example, thegripping surfaces 704 may have a high degree of surface roughness.

At least one cutting block 710 may be connected to at least one arm 682.Each cutting block 710 is movable relative to the corresponding arm 682.For example, each cutting block 710 may be rotatably connected to thecorresponding arm 682, where the axis of rotation is parallel to thelongitudinal axis of that arm 682. However, at least one cutting block710 may be connected to the corresponding arm 682 in a different manner.Each cutting block 710 includes a first element 712 having an end 714and a cutting surface 716, and a second element 718 angled relative tothe first element 712. Each end 714 has an upper edge 715. Both thefirst element 712 and the second element 718 may be connected to orformed as a unit with a third element 722 that extends to thecorresponding arm 682, where the third element 722 is rotatable orotherwise movable relative to that arm 682. Alternately, the secondelement 718, or the first element 712, extend to and connect to thecorresponding arm 682. At least one second element 718 may include atleast one gripping surface 720 defined thereon or connected thereto. Thegripping feature or features 720 may be any structure or mechanism thatfacilitates actuation of the second element 718 by a user. As oneexample, the gripping surfaces 720 on a second element 718 may be anumber of bumps formed in or connected to that second element 718. Asanother example, the gripping surface 720 may be a rubberized or roughsurface on the second element 718.

The upper edges 715 of the ends 714 of the cutting blocks 710 aresubstantially the same length as one another, and are substantiallyparallel to one another. The length of each upper edge 715 is related tothe length of the anastomosis between the graft vessel 404 and thetarget vessel 580. Referring also to FIG. 73, the anastomosis length 770is measured along the longitudinal axis of the target vessel 580, and isthe distance between the two most longitudinally-distant points ofcontact between the perimeter of the end of the graft vessel 404 (theperimeter being substantially continuous and adjacent to the roots 405of the flaps 408) and the side of the target vessel 580. As part of theanastomosis procedure, an arteriotomy 774 may be made in the targetvessel, where that arteriotomy has a known length. The arteriotomylength 772 is measured along the longitudinal axis of the target vessel580, and is the distance between the two most longitudinally-distantends of the arteriotomy. The arteriotomy in the target vessel 580 isenclosed by the circumference of the end of the graft vessel 404, andthe anastomosis length 770 is greater than the arteriotomy length 772,thereby preventing leakage at the anastomosis site.

The graft vessel 404 is angled relative to the parallel upper edges 715such that one end of each edge 715 is positioned substantially at oneside of the graft vessel 404 and the other end of each edge 715 ispositioned substantially at the opposite side of the graft vessel 404.That is, the graft vessel 404 is positioned such that the edges 715 ofthe cutting blocks 710 define a chord across the graft vessel 404, wherethe chord has a length substantially equal to the length of the edges715. In this way, the end of the graft vessel 404 can be prepared to asubstantially constant preselected length, and the graft vessel 404 isheld across the entire length of the chord. Further, graft vessels 404of different widths each can be prepared such that the roots 405 of theflaps 408 each have the same substantially constant preselected length,simply by changing the angle of the graft vessel 404 relative to theedges 715 of the cutting blocks. The length of the chord across thegraft vessel 404 is substantially equal to the anastomosis length 770.Further, the length of the chord across the graft vessel 404 issubstantially equal to the length of the roots 405 of the flaps 408, andthus is related to the size of the flaps 408. The arteriotomy length 772may be substantially constant across different sizes of graft vessel404. By ensuring that the roots 405 of the flaps 408 are prepared to apreselected length across a spectrum of sizes of graft vessels 404, theanastomosis length 770 in turn is ensured to be longer than thearteriotomy length 772, thereby preventing leakage.

The shims 702 may be sized to be shorter than the length of thecorresponding jaw 700 and/or the upper edge 715 of the cutting block710. However, the shims 702 may be as long as, or longer than, thecorresponding jaw 700 and/or the upper edge 715 of the cutting block710. Each shim 702 may be longitudinally offset from the longitudinalcenter of the corresponding jaw 700 and/or cutting block 710. Referringin particular to FIG. 84, each shim 702 extends above the correspondingjaw 700 to a location below the upper edge 715 of the correspondingcutting block 710. In this way, adequate clearance is provided betweenthe shims 702 and the staple holder 38 of the anastomosis tool 300 whenthe transfer clamp 672 is opened, as described below.

Referring to FIGS. 81-85, each cutting block 710 is moveable between anopen position for receiving a graft vessel and a closed position forholding a graft vessel. Each cutting block 710 is positioned at alongitudinal position on the corresponding arm 682 that is substantiallythe same as the longitudinal position of the jaw 700 of that arm 682. Inthe closed position, the ends 714 of the first elements 712 of thecutting blocks 710 are positioned in proximity to and substantiallyabove the gripping surfaces 704 of the corresponding jaws 700 andsubstantially above the corresponding jaws 700.

Referring also to FIG. 86, at least one of the cutting blocks 710 mayinclude a snap 724 extending downward from it. The snap 724 may beconfigured in any appropriate manner to engage a corresponding receiver726 defined in or connected to the corresponding jaw 700. As oneexample, the snap 724 may include a leg 728 connected at one end to thecorresponding cutting block 710, and a ledge 730 connected to the otherend of the leg 728, where the ledge 730 extends at an angle to the leg728. The ledge 730 may be straight or curved. As a result, the snap 724may have an L-shaped or J-shaped cross section. Alternately, the ledge730 is connected to a different portion of the leg 728, or is omitted.The receiver 726 in the jaw 700 is shaped to engage the ledge 730 of thecorresponding snap 724 when the cutting block 710 is in the closedposition. That is, contact between the receiver 726 and the ledge 730restrains the ledge 730 from moving out of the receiver 726 until apredetermined amount of force is applied. As one example, the receiver726 includes a notch 732 defined therein. As the cutting block 710 isrotated toward the jaw 700, the ledge 730 contacts the surface of thejaw 700 in proximity to the receiver 726. The application of force onthe cutting block 710 toward the jaw 700 causes the snap 724 to deflect,allowing the ledge 730 to move into the corresponding receiver 726 andengage the corresponding notch 732 therein.

Referring also to FIG. 83, a slot 756 extends along each arm 682 of thetransfer clamp 672. Each slot 756 is shaped and sized to receive acorresponding wing 760 of the staple holder 38. The slots 756 may beangled such that the staple holder 38 can be inserted only in a singleorientation, to ensure that the flaps 408 are positioned appropriatelyrelative to the anvil 10 and the staple holder 38. Further, the slots756 are spaced apart from one another a particular distance such thatthe wings 760 each can be received into a corresponding slot 756. At theproximal end of each slot 756 is a wall 758. A notch 759 may be formedinto at least one arm 682, where each notch 759 opens into acorresponding slot 756 and faces the space between the arms 682. Eachnotch 759 is positioned to engage the bump 762 on a particular wing 760,as described below.

Graft Vessel Preparation—Graft Manipulator

Referring to FIG. 87, a graft manipulator 740 is shown. The graftmanipulator 740 includes a handle 742 with two arms 744 biased apartfrom one another at their distal ends and connected together, such aswith a base 746, at their proximal ends. The handle 742 may be a unitarystructure, such as a single piece of molded plastic. The degree to whichthe distal ends of the arms 744 are biased apart may be related to thesize and shape of the base 746 that connects the arms 744, and theproperties of the material used to form the base 746. A prong 748extends from the distal end of each arm 744. Each prong 748 may beconnected to the corresponding arm 744, or formed into the correspondingarm 744. The prongs 748 are sized such that both can fit into an end ofa graft vessel 404 at the same time, and are finished and contoured todo so without damaging the end of the graft vessel 404. As one example,each prong 748 is a thin metal rod with a blunt distal end. Each prong748 is connected to the corresponding arm 744 by a pressure fit, by oneor more clips, by adhesive, or by any other appropriate mechanism,structure or method. Because the distal ends of the arms 744 are biasedapart, the prongs 748 at the distal ends of the arms 744 are biasedapart as well.

Alternately, one or more of the retractor mount 620, the transfer clampassembly 670, and/or the graft manipulator 740 are not utilized.Instead, one or more other preparation tools may be used, such as thegraft vessel preparation device of U.S. Pat. No. 6,554,764 to Vargas et.al., which is hereby incorporated by reference in its entirety.

Alternately, where the staple holder 38 includes a graft affixer 910,the retractor mount 620, the transfer clamp assembly 670, and/or thegraft manipulator 740 need not be utilized, and other specializedpreparation tools need not be used, as described in greater detailbelow.

Preparing the Graft Vessel

Referring to FIGS. 79-80A, to prepare a graft vessel 404 foranastomosis, the retractor mount 620 is attached to a retractor 750. Todo so, the clamp elements 622, 624 are slid relative to one another tocreate a gap between the engagement features 626, 628. This sliding isperformed against the bias that urges the engagement features 626, 628toward one another. The retractor mount 620 is then moved relative tothe retractor 750 such that a portion of the retractor 750 is positionedbetween the engagement features 626, 628. The clamp elements 622, 624are then released, and the engagement features 626, 628 move toward oneanother to the closed position and engage the retractor 750. Next, theactuator 640 is rotated to compress the clamp elements 622, 624 togetherand hold them in the closed position, secured to the retractor 750.Alternately, the retractor mount 620 is connected to the retractor 750in a different manner.

The transfer clamp assembly 670 is then connected to the retractor mount620. For example, the extension arm 674 is snapped into engagement withthe clip 650 of the holder 648, where the clip 650 holds the extensionarm 674 by a pressure fit. The transfer clamp assembly 670 is thenrotated to a desired position, by rotating the holder 648. The holder648 is retained in the desired position by engagement between the stubor stubs 662 of the holder 648 and the corresponding trough or troughs658 of the retractor mount 620. The transfer clamp assembly 670 may beconnected and/or oriented relative to the retractor mount 620 in adifferent way, if desired.

Next, referring to FIG. 87, the arms 744 of the graft manipulator 740are pressed together by the user, overcoming the bias that urges thedistal ends of the arms 744 apart. As a result, the prongs 748 of thegraft manipulator 740 are brought into proximity with or contact withone another. The prongs 748 are then inserted into the lumen of thegraft vessel 404, and pressure on the arms 744 of the graft manipulator740 is gradually released. The prongs 748 move apart due to the biasingapart of the distal ends of the arms 744, resulting in the end of thegraft vessel 404 flattening and becoming taut. The force exerted by thegraft manipulator 740 is controlled such that the end of the graftvessel 404 is flattened, but not damaged or overly stretched. Such forcecontrol is accomplished such as by selecting the material and size ofthe base 746 of the graft manipulator 740, as described above.Optionally, the graft vessel 404 may be marked, such as with ink, alonga length thereof. Referring also to FIG. 73, this marking may end at ornear the location on the graft vessel 404 that will be positioned at thetoe 585 of the anastomosis. The toe 585 of the anastomosis is the end ofthe anastomosis at which the outer surface of the graft vessel 404 formsan obtuse angle with the outer surface of the target vessel. The heel587 of the anastomosis is the opposite end of the anastomosis, at whichthe outer surface of the graft vessel 404 forms an acute angle with theouter surface of the target vessel.

Referring also to FIG. 83, the user then compresses the finger pads 698toward one another, causing the arms 682 of the transfer clamp 672 tomove to the open position against the bias that urges them toward theclosed position. Referring also to FIG. 87, the graft manipulator 740 isthen moved relative to the transfer clamp 672 to place the graft vessel404 between the arms 682 of the transfer clamp 672. The graft vessel 404is placed between the arms 682 such that it is located between theopposed jaws 700 of the arms 682. The cutting blocks 710 are initiallyconfigured such that the ends 714 of each first element 712 is inproximity to the jaw 700 of the corresponding arm 682. The snap 724 ofeach cutting block 710 may engage the corresponding receiver 726 to holdthe cutting block 710 in that position. Thus, the graft vessel 404 isalso placed between the opposed ends 714 of the first elements 712 ofthe cutting blocks 710. The graft vessel 404 may be oriented such thatthe marked toe of the graft vessel 404 is oriented distally.

The graft manipulator 740 is used to angle the graft vessel 404 relativeto the edges 715 of the cutting blocks 710 such that one end of eachedge 715 is positioned substantially at one side of the graft vessel 404and the other end of each edge 715 is positioned substantially at theopposite side of the graft vessel 404. As described above, this definesa chord of a known length across the graft vessel 404. Advantageously,the graft vessel 404 is positioned such that its end extends at least 5millimeters above the edges 715 of the cutting blocks 710. Because thetransfer clamp assembly 670 is held by the retractor mount 620, a singleuser can manipulate the graft vessel 404 relative to the transfer clamp672 easily.

The finger pads 698 are then released by the user, allowing the arms 682of the transfer clamp 672 to return to a closed position. Referring alsoto FIG. 88, the jaws 700 and the ends 714 of the first elements 712 ofthe cutting blocks 710 close onto and hold the graft vessel 404. Thegripping surfaces 704 of the jaws 700 and the gripping surfaces 720 ofthe cutting blocks 710 facilitate engagement with the graft vessel 404,such that the graft vessel 404 is held securely in the selectedorientation. That is, the jaws 700 and/or cutting blocks 710 hold thegraft vessel 404 at the selected angle relative to the edges 715 of thecutting blocks 710. That selected angle is related to theconstant-length chord defined on the graft vessel 404 by the edges 715of the cutting blocks 710. The graft vessel 404 can be reoriented bycompressing the finger pads 698 together again and moving the graftmanipulator 740 relative to the transfer clamp 672. The arms 744 of thegraft manipulator 740 are then compressed together again such that theprongs 748 can be removed from the lumen of the graft vessel 404, andthe graft manipulator 740 is set aside.

One or more flaps 408 are then created in an end of the graft vessel404. Referring also to FIG. 89, a scissors 752 may be used to create theflaps. The scissors 752 have two jaws 754 movable relative to oneanother. The scissors 752 may be Potts scissors or any other appropriatesurgical scissors. The jaws 754 of the scissors are moved apart from oneanother, and one of the jaws 754 is inserted into the lumen of the graftvessel 404. The scissors 752 are then closed to make a substantiallystraight incision in the graft vessel 404 substantially longitudinallyalong the graft vessel 404. Advantageously, the first incision is madealong the line marked on the outer surface of the graft vessel 404. Theincision is continued until the upper surfaces of the second elements718 of the cutting blocks 710 are reached. That is, the upper surfacesof the second elements 718 of the cutting blocks 710 act as stops. Asecond incision is then made in the end of the graft vessel 404,substantially opposite from the first incision. The second incision isalso substantially straight and substantially longitudinal, and isstopped by the upper surfaces of the second elements 718 of the cuttingblocks 710. As a result of the two incisions, two tissue flaps 408 arecreated, each of which ends substantially at the upper surfaces of thesecond elements 718 of the cutting blocks 710. Thus, as described above,the length of the root 405 of each flap 408 is substantially equal tothe anastomosis length 770 and to the length of the upper edge 715 ofeach cutting block 710. The flaps 408 are substantially the same sizeand shape as one another. Alternately, the flaps 408 are sized and/orshaped differently. Alternately, only a single incision is made in thegraft vessel 404 to form a single flap 408, or more than two incisionsare used to create more than two flaps 408. Alternately, a scalpel orother mechanism or structure may be used instead of or in addition tothe scissors 752 to create the flap or flaps 408 at the end of the graftvessel 404.

Referring also to FIG. 91, after the incisions have been made in thegraft vessel 404, the cutting blocks 710 are moved to the open position,such that the ends 714 of the first elements 712 of the cutting blocks710 are positioned away from the graft vessel 404. Where a snap or snaps724 are used, the snap or snaps 724 are disengaged from thecorresponding receiver or receivers 726. Each cutting block 710 may bedisengaged from the corresponding receiver 726 and/or moved to an openposition by gripping or pushing the gripping surface 720 on the secondelement 718 of the cutting block 710. The cutting blocks 710 areconfigured to rotate from the open to the closed position, as describedabove. Alternately, at least one cutting block 710 is configured toslide relative to the corresponding arm 744, or rotate about an axisthat is not parallel to the axis of rotation of a different cuttingblock 710. Alternately, the cutting blocks 710 may be configured to becompletely removed from the transfer clamp 672 rather than moved to anopen position. After the cutting blocks 710 have been moved to the openposition, the jaws 700 hold the graft vessel 404 in place atsubstantially the same angle at which it was previously held, as aresult of the bias urging the arms 682 and thus the jaws 700 together.The cutting blocks 710 may be moved to the open position to avoidinterference with the staple holder 38 or other component of theanastomosis tool 300 when the transfer clamp assembly 670 engages atleast part of the anastomosis tool 300. Alternately, the cutting blocks710 may be configured to remain in the closed position and avoidinterference with the staple holder 38 or other component of theanastomosis tool 300. If so, at least one cutting block 710 optionallymay be integrated with the corresponding jaw 700. Alternately, at leastone cutting block 710 is omitted altogether, such that there is no needto move cutting blocks 710 from an open position to a closed position.Instead, the incision or incisions made to create the flaps 408 arestopped by surfaces of the jaws 700, arms 744 and/or other structure orstructures.

The transfer clamp assembly 670 is then disconnected from the retractormount 620, and held by the user or rested in a secure position withinthe patient's chest. Alternately, the transfer clamp assembly 670 may beheld by another person, or placed in a different location. Referringalso to FIG. 92, the anastomosis tool 300 is then connected to theretractor mount 620. For example, the shaft 304 of the anastomosis tool300 may snap into the clip 650 of the holder 648, wherein the clip 650holds the shaft 304 with a pressure fit. However, the anastomosis tool300 may be connected to the retractor mount 620 in a different way, ifdesired. The anastomosis tool 300 may be oriented such that the anvil 10is oriented substantially upward. Where the graft clips 412 are used,they are moved to the open position if they are not already in the openposition.

Next, the transfer clamp 672 is slid onto the staple holder 38.Referring also to FIGS. 57 and 59C-D, the staple holder 38 includes oneor more wings 760 extending outward therefrom. Each wing 760 may includeat least one bump 762 defined thereon. The bump or bumps 762 may bepositioned on an upper surface of the corresponding wing 760, and may beoriented substantially laterally. As the transfer clamp 672 is movedtoward the staple holder 38, each wing 760 of the staple holder 38 isreceived into a corresponding slot 756. The shape of the slots 756defines the path of travel of the transfer clamp 672 relative to thewings 760 and therefore relative to the staple holder 38.Advantageously, the slots 756 are substantially linear, resulting intranslation of the transfer clamp 672 relative to the staple holder 38.However, the slots 756 may define a different path if desired. As thetransfer clamp 672 slides relative to the staple holder 38, each flap408 slides between the anvil 10 and an arm 402 of the staple holder 38.The flaps 408 may be held with forceps or another tool or tools duringthis sliding. As the transfer clamp 672 slides relative to the wings760, the bump 762 on at least one wing 760 enters the corresponding slot756. The combined thickness of the wing 760 and the bump 762 is slightlylarger than the height of the slot 756. However, the material of thewing 760 and bump 762, and/or the material of the corresponding arm 682,has enough compliance to allow for compression of the wing 760 and bump762 and/or expansion of the corresponding slot 756. Further, theentrance to each slot 756 is shaped and/or finished to allow smoothentry of the bump 762 into that slot 756. As each bump 762 continues totranslate, it enters a corresponding notch 759. The height of the notch759 is larger than the height of the slot 756 and at least as large asthe combined thickness of the wing 760 and bump 762, thereby allowingthe bump 762 to move into that notch 759 freely.

Sliding of the transfer clamp 672 continues until each wing 760encounters the wall 758 at the proximal end of the corresponding slot756, at which time motion of the transfer clamp 672 stops. Each notch759 has a substantially vertical distal end 761. Motion of the transferclamp 672 away from the wall 758 causes contact between the distal end761 of the notch 759 and the bump 762. This contact prevents the bump762 from re-entering the slot 756, and thereby prevents the transferclamp 672 from disconnecting from the staple holder 38. That is, thenotches 759 and corresponding bumps 762 provide for positive engagementbetween the transfer clamp 672 and the staple holder 38. At the timetranslation of the transfer clamp 672 stops, the bump 762 of each wing760 may be in close proximity to the distal end 761 of each notch 759,or in contact with the distal end 761 of each notch 759. This proximitylimits the linear travel of the transfer clamp 672 relative to thestaple holder 38 while the two are connected together. By minimizing orsubstantially elimination motion between the transfer clamp 672 and thestaple holder 38 after positive engagement with one another, the stapleholder 38 and the transfer clamp 672 are registered relative to oneanother in a desired position. The flaps 408 are thereby registered withthe staple holder 38 in a desired position relative to the flapreceiving surfaces 406 and/or other elements of the staple holder 38. Inthis way, the transfer clamp 672 reliably positions the flaps 408 at apreselected location relative to the staple holder 38. This preselectedlocation is such that each flap 408 is positioned in proximity to acorresponding flap receiving surface 406, and such that each flap 408extends distal to the most distal connector bay 448 of the arm 402 ofthe staple holder 38 and proximal to the most proximal connector bay 448of the arm 402 of the staple holder 38. In this way, each flap 408 ispositioned relative to the staple holder 38 such that each connector 464held within the corresponding arm 402 of the staple holder 38 isdeployable through that flap 408. Next, referring also to FIGS. 58-59,each flap 408 is draped onto the corresponding flap receiving surface406 of the corresponding arm 402. Forceps or a different tool may beused to place each flap 408 onto at least one spike 410 extending fromthe flap receiving surface 406. The shims 702 are configured to hold thegraft vessel 404 substantially in the middle thereof, in order tofacilitate draping the flaps 408 onto the spikes 410 withoutsubstantially crinkling the flaps 408 or the graft vessel 404. Each shim702 extends above the corresponding jaw 700 to a location below theupper edge 715 of the corresponding cutting block 710. Thus, after thecutting blocks 710 are moved to the open position, the shims 702 holdthe graft vessel 404 at a location spaced apart from and underneath theflaps 408. This space between the shims 702 and the flaps 408 allows theflaps 408 to be tensioned when placed on the spikes 410. The flaps 408are tensioned when they are placed onto the spikes 410, withouttensioning them to the point where tissue elasticity is lost. Byproviding tension in the flaps 408, particularly at the locations on theflaps 408 that correspond to the heel 587 and the toe 585 of theanastomosis, sealing of the anastomosis is facilitated. After the flap408 is placed onto one or more spikes 410, the poke-through tip 678 ofthe extension arm 674 is used to push the flap 408 down onto the one ormore spikes 410. The spike or spikes 410 then hold the correspondingflap 408 in place. Advantageously, each flap 408 engages two or morespikes 410, and each flap 408 is held substantially taut.

The spikes 410 alone are sufficient to hold the flaps 408 onto the arms402 of the staple holder 38. Where graft clips 412 are used, the graftclips 412 are moved to the closed position after the flaps 408 have beenpushed down onto the spikes 410. The graft clips 412 provide additionalholding force to secure the flaps 408 to the arms 402 of the stapleholder 38. Optionally, where the arms 410 of the staple holder 38 aresufficiently close to one another to hold the graft vessel 404 in itsunprepared state, the transfer clamp 672 may be omitted. If so, theflaps 38 may be prepared in place as the graft vessel 404 is heldbetween the arms 410, and then secured to the spikes 410.

After the flaps 408 have been secured to the staple holder 38, thefinger pads 698 are compressed to move the arms 682 of the transferclamp 672 apart from one another. Such motion of the arms 682 alsocauses the arms 682 to move away from the staple holder 38, freeing it.Referring also to FIG. 84, each shim 702 extends above the correspondingjaw 700 to a location below the upper edge 715 of the correspondingcutting block 710. In this way, as the arms 682 move away from oneanother, the shims 702 substantially do not interfere with the stapleholder 38, allowing the transfer clamp 672 to be detached from theanastomosis tool 300. Alternately, the shims 702 may be flexible, andmay be positioned higher relative to the upper edge 715 of thecorresponding cutting block. In this way, the shims 702 flex uponcontacting the staple holder 38, allowing the transfer clamp 672 to openand release the staple holder 38. The anastomosis tool 300 is ready forperforming anastomosis, and the transfer clamp assembly 670 may be setaside.

Alternately, where the staple holder 38 includes a graft affixer 910,the graft vessel 404 may be prepared differently, without the use of theretractor mount 620, the transfer clamp assembly 670, and/or the graftmanipulator 740. Referring to FIG. 133, a single incision 924 is made atan end of the graft vessel 404. The incision 924 extends substantiallylongitudinally along the graft vessel 404. The incision 924 may be madewith any appropriate surgical tool, such as a Potts scissors. When theincision 924 is made, the graft vessel 404 may be held by hand, with asurgical clamp, or in any other suitable manner. Advantageously, theincision 924 is substantially one centimeter long, although it may belonger or shorter if desired.

Referring also to FIGS. 130-132 and 134, the graft vessel 404 is movedbetween the arms 402 of the staple holder 38, such that the incised endthereof is in proximity to the staple holder 38. The graft vessel 404 isthen connected to the graft affixer 910. Advantageously, a location onthe graft vessel 404 close to and proximal to the incision 924 isconnected to the graft affixer 910; this location corresponds to theheel of the anastomosis to be performed and may be referred to as theheel of the graft vessel 404. Alternately, a different location on thegraft vessel 404 is connected to the graft affixer 910. The graft vessel404 is connected to the graft affixer 910 in any suitable manner. As oneexample, where the graft affixer 910 is a spike, the graft vessel 404 ispushed down onto the spike or the leg 1150 such that it penetrates awall of the graft vessel 404 in whole or in part. The graft vessel 404may be everted onto the spike or the leg 1150. A poke-through tip 678such as described above, or similar structure or mechanism, optionallymay be provided and utilized to push the graft vessel 404 onto the spikeor the leg 1150. The poke-through tip 678 may be connected to a rod orother member (not shown) to facilitate its use. Similarly, where thegraft affixer 910 is a hook, the graft vessel 404 is pushed onto thehook such that it penetrates a wall of the graft vessel 404 in whole orin part. As another example, where the graft affixer 910 is a clip, thegraft vessel 404 is clipped and held by the clip. The graft vessel 404may be everted into the clip. Where the graft affixer 910 is configureddifferently, the graft vessel 404 is connected to it in any suitablemanner.

Next, the graft vessel 404 is angled relative to the arms 402 of thestaple holder 38, as the heel of the graft vessel 404 is heldsubstantially at a known position by the graft affixer 910. That is, thegraft affixer 910 registers the heel of the graft vessel 404 to thestaple holder 38. The graft vessel 404 is angled relative to at leastone measurement feature 922 such that one end of the measurement feature922 is positioned substantially at one side of the graft vessel 404 andthe other end of the measurement feature 922 is positioned substantiallyat the opposite side of the graft vessel 404. That is, the graft vessel404 is positioned such that at least one measurement feature 922 definesa chord across the graft vessel 404. In this way, the end of the graftvessel 404 can be prepared to a substantially constant preselectedlength corresponding to the length of at least one measurement feature922. Further, graft vessels 404 of different widths each can be handledsimply by changing the angle of the graft vessel 404 relative to atleast one measurement feature 922. The length of the chord across thegraft vessel 404 is substantially equal to the anastomosis length 770.The arteriotomy length 772 may be substantially constant acrossdifferent sizes of graft vessel 404. By ensuring that the graft vessel404 is prepared substantially to a preselected chord length relative tothe staple holder 38 across a spectrum of sizes of graft vessels 404,the anastomosis length 770 in turn is ensured to be longer than thearteriotomy length 772, thereby preventing leakage.

The flap 408 is then everted onto the arms 402 of the staple holder 38.If one or more spikes 410 extend outward from at least one of the flapreceiving surfaces 406 of the staple holder 38, the flap 408 is evertedonto one or more of those spikes 410. As the flap 408 is placed onto thecorresponding flap receiving surface 406, one or more of the spikes 410penetrate the flap 408 partially or completely, thereby assisting inholding the flap 408 in place against the flap receiving surface 406.The poke-through tip 678 or other tool optionally may be used to pushthe flap 408 down onto the one or more spikes 410. The spike or spikes410 then hold the corresponding flap 408 in place. Advantageously, eachflap 408 engages two or more spikes 410, and each flap 408 is heldsubstantially taut. Alternately, at least one graft clip 412 is used tohold the flap 408 to the staple holder 38, instead of or in addition toat least one spike 410.

Optionally, referring to FIG. 155, the tissue effector 400 may bemovable to a graft preparation position relative to the shaft 304. Inthe graft preparation position, the staple holder 38 is oriented atleast partially upward, or at least partially toward the user, tofacilitate the connection of the graft vessel 404 to it. The tissueeffector 400 may be movable to the graft preparation position in anysuitable manner. As one example, the shaft 304 may simply be rotatedabout its longitudinal axis within the clip 650 of the retractor mount620, such that the staple holder 38 is oriented at least partiallyupward. As another example, where the cog 282 is used, the user maydepress at least one of the buttons 278, disengaging the teeth 284 ofthe cog 282 from the detents 310 of the receiving opening 309. Thetissue effector 400 is then rotated to the graft preparation position.The buttons 278 are then released, allowing the teeth 284 of the cog 282to engage once again the detents 310 of the receiving opening 309. Thecog 282 is thus held securely in place in its new orientation. Asanother example, where the articulated shaft includes a hinge 956 and alocktab 954 such as shown in FIGS. 140-141, the tissue effector 400 maybe rotated about the hinge 956 until it reaches the graft preparationposition. The locktab 954 is then rotated about the locktab hinge 958from the first position to the second position, thereby substantiallylocking the tissue effector 400 in place in the graft preparationposition.

Preparation of the graft vessel 404, where the graft affixer 910 isused, has been described in terms of a graft vessel 404 having a singleincision 924 at an end thereof, such that a single flap 408 is formed.However, a graft vessel 404 having multiple incisions 924 in an endthereof, and therefore multiple flaps 408, may be utilized with a stapleholder 38 having a graft affixer 910. Alternately, no flaps 408 arepresent in the graft vessel 404, and the end of the graft vessel 404 iseverted onto the graft affixer 910. Further, the retractor mount 620,the transfer clamp assembly 670, and/or the graft manipulator 740 neednot be used in conjunction with a staple holder 38 having a graftaffixer 910. However, one or more of those tools may be used, ifdesired.

Operation of Anastomosis Tool—Pre-Deployment Configuration

Referring also to FIG. 70, the anastomosis tool 300 is initially in apre-deployment configuration. In this configuration, the distal arm 518of the rocker 508 is at an uppermost position, the trigger 308correspondingly extends outward from the handle 302 to its greatestextent, and the proximal arm 514 of the rocker 508 is at a lowermostposition. The distal end 520 of the distal arm 518 of the rocker 508 mayengage the contact surface 548 of the distal slider 534 at or near theuppermost end of the contact surface 548. This contact may be betweenthe posts 544 of the distal arm 518 and the contact surface 548, and/orbetween another portion of the distal arm 518 and the contact surface548. The stops 596 of the holder 594 hold the distal slider 534substantially in place against the proximal bias exerted by the spring540. Alternately, where the holder 594 is not used, contact between therigid distal arm 518 and the contact surface 548 holds the distal slider534 substantially in place against the proximal bias exerted by thespring 540. In the pre-deployment configuration, the proximal end 516 ofthe proximal arm 514 may be spaced apart from the lower portion 530 ofthe proximal slider 522, or may be in contact with the lower portion 530of the proximal slider 522. The proximal slider 522 is biased distallyto its most distal possible position. Alternately, the proximal slider522 is positioned differently in the pre-deployment configuration.Alternately, the rocker 508 and/or the trigger 308 may be in a differentposition in the pre-deployment configuration, particularly where therocker 508 and/or trigger 308 are shaped or configured differently thanshown in FIG. 70. If so, the rocker 508 may engage the proximal slider522 and/or the distal slider 534 in a different manner than describedabove.

Referring also to FIG. 77, when the handle 302 is in the pre-deploymentconfiguration, the time is t=0. The position 590 of the proximal slider522 is at an initial position, and the position 592 of the distal slider534 is also at an initial position. The positions 590, 592 of thesliders 522, 534 on the graph of FIG. 77 are qualitative, and are shownwith respect to an arbitrary point selected between them. That is, thegraph of FIG. 77 illustrates an exemplary set of motions of the sliders522, 534 over time.

The first cable or cables 480 are connected to the proximal slider 522and the second cable 490 is connected to the distal slider 534, asdescribed above. In the pre-deployment configuration, both cables 480,490 include some slack, such that a small initial motion of the trigger308 takes up the slack and causes the cables 480, 490 to becometensioned. In this way, small motions of the trigger 308 beforedeployment is intended do not begin the actuation of the anastomosistool 300. Alternately, one or more of the cables 480, 490 are tensionedin the pre-deployment configuration.

The second cable 490 is also connected to the sled 482 in the tissueeffector 400, as described above. Referring also to FIGS. 64 and 68-69,in the pre-deployment configuration the sled 482 is positioned such thateach ramp element 446 is located within the corresponding passage 440 inthe corresponding arm 402, proximal to the connector bays 448.Similarly, in the pre-deployment configuration the sled 482 ispositioned such that each vein knife 432 is located proximal to the veinflap 408 held between the graft clip 412 and the corresponding flapreceiving surface 406. Alternately, the sled 482 is positioneddifferently in the pre-deployment configuration. For example, each rampelement 446 may be positioned initially in a location distal to theconnector bays 448. Referring also to FIG. 72, each flap 408 is heldbetween a graft clip 412 and a flap receiving surface 406 as describedabove, such that the graft vessel 404 extends between the arms 402 ofthe tissue effector 400. The flaps 408 are held on the undersides of thearms 402. Each flap 408 may be held by the corresponding graft clip 412such that a portion of the flap 408 at its root 405, which is theportion of the flap 408 at or in proximity to its intersection with thetubular portion of the graft vessel 404, is exposed. The root 405 ofeach flap 408 may be positioned to contact the outer surface of thetarget vessel 580, as described in greater detail below.

Optionally, the orientation of the tissue effector 400 may be changedrelative to the handle 302. Thus, the tissue effector 400 can beoriented relative to the target vessel such that the anvil arm 14 isaligned with it, and the handle 302 can be placed in a convenientposition for the user. As one example, to re-orient the tissue effector400, the user depresses the buttons 278, disengaging the teeth 284 ofthe cog 282 from the detents 310 of the receiving opening 309. Thetissue effector 400 is then rotated to the desired orientation. Thebuttons 278 are then released, allowing the teeth 284 of the cog 282 toengage once again the detents 310 of the receiving opening 309. The cog282 is thus held securely in place in its new orientation. As anotherexample, where the articulated shaft includes a hinge 956 and a locktab954 such as shown in FIGS. 140-141, the tissue effector 400 is rotatedabout the hinge 956 until it reaches the desired position. The locktab954 is then rotated about the locktab hinge 958 from the first positionto the second position, thereby substantially locking the tissueeffector 400 in place in the selected position.

Operation of Anastomosis Tool—Anvil Insertion

Referring to FIGS. 34 and 74, in the pre-deployment configuration, thedistal end of the anvil arm 14 is spaced apart from the staple holder38. Referring also to FIG. 75, the anvil arm 14 is inserted through thewall of the target vessel 580. The target vessel 580 may be a coronaryartery, if the anastomosis tool 300 is used in the course of a CABGprocedure, or any other appropriate bodily vessel or structure.Advantageously, the anvil arm 14 has a cross-section small enough toallow it to enter the target vessel 580 easily and to result in minimalor no leakage from the target vessel after the anvil arm 14 is removed.The distal tip of the anvil arm 14 may be sharp such that the anvil arm14 itself penetrates the wall of the target vessel 580, resulting in anopening in the wall of the target vessel 580 substantially the same sizeas the cross-section of the anvil arm 14. Alternately, a sharpretractable projection, such as but not limited to the blade 78 of FIGS.13-14 or the blade 84 of FIGS. 15-16, is provided at the distal end ofthe anvil arm 14. The retractable projection is extended to allow thedistal end of the anvil arm 14 to penetrate the wall of the targetvessel 580, then retracted into the anvil arm 14. The retractableprojection may be a wire, a blade, a substantially conical member, ascrew or a screw-tipped rod, or any other sharp structure or mechanismcapable of penetrating the wall of the target vessel 580. Such aretractable projection alternately may be as described in U.S. Pat. No.7,530,987, issued May 12, 2009, previously incorporated by reference. Asanother example, a separate mechanism or structure is used to penetratethe wall of the target vessel 580, and the anvil arm 14 is laterinserted through that penetration. If so, the distal end of the anvilarm 14 may be substantially blunt. Alternately, the cutter 200 includesa sharp point at its distal end, where that sharp point extends out ofthe distal end of the anvil arm 14 to puncture the wall of the targetvessel 580. If so, the cutter 200 may be actuated in a direction thereverse of that described below.

Referring also to FIGS. 36 and 75, after insertion, the distal end ofthe anvil arm 14 enters the lumen of the target vessel 580. The anvilarm 14 is advanced into the target vessel 580 until a tissue stop 220 onthe anvil arm 14 encounters the edge of the penetration in the wall ofthe target vessel 580. The tissue stop 220 is substantially flat and/orblunt, and extends upward or in another direction relative to the anvilarm 14 to increase the height and/or width of the anvil arm 14. Thetissue stop 220 increases the cross-section of the anvil arm 14 suchthat the anvil arm 14 cannot easily move further into the penetration inthe wall of the target vessel 580 after the tissue stop 220 encountersthe outer wall of the target vessel 580. Because the tissue stop 220 isblunt, it does not penetrate the wall of the target vessel 580 or act toexpand the size of the existing penetration. Thus, the distance betweenthe distal end of the anvil arm 14 and the tissue stop 220 substantiallydetermines how much of the anvil arm 14 is allowed into the lumen of thetarget vessel 580.

Optionally, the distal end of the anvil arm 14 is stabilized afterinsertion into the target vessel 580. This stabilization may beperformed by, for example, extending pins (not shown) from the stapleholder 38 to the anvil arm 14, where the pins act to hold the distal endof the anvil arm 14 substantially in place. The pins may be sized andshaped to fit into depressions, slots or other features on the anvil arm14. In this way, potential deflection of the distal end of the anvil arm14 may be further reduced without the need for increasing the stiffnessof the anvil arm 14. After the connectors 464 have been deployed, thepins are retracted or otherwise moved away from the anvil arm 14,freeing it. Different or additional mechanisms, structures or methodsmay be used to stabilize the anvil arm 14. Optionally, a different partof the anvil arm 14 is stabilized in addition to or instead of thedistal end of the anvil arm 14.

Referring also to FIGS. 93-95, when the anvil arm 14 is inserted intothe lumen of the target vessel 580, the distal end of the shield 290 isspaced apart from the anvil arm 14. As a result, as the distal end ofthe anvil arm 14 enters the lumen of the target vessel 580, the distalend of the shield 290 is spaced apart from the distal end of the anvilarm 14 and does not enter the anvil entry hole 584. Consequently, theshield 290 remains outside the target vessel 580, and at least part ofthe shield 290 may be spaced apart from the wall of the target vessel580. The location of the connection between the shield 290 and the anvil10 remains outside the target vessel 580. Alternately, referring toFIGS. 106 and 144-145, where the shield 290 is connected to the stapleholder 38, the shield 290 is in greater proximity to the staple holder38 than to the anvil arm 14. The tissue effector 400 is in the openposition, with at least part of the staple holder 38 spaced apart fromthe wall of the target vessel 580. Consequently, the shield 290 remainsoutside the target vessel 580, and at least part of the shield 290 maybe spaced apart from the wall of the target vessel 580.

Operation of Anastomosis Tool—Closing Tissue Effector

Next, referring to FIGS. 44 and 70, an operator depresses the trigger308 of the anastomosis tool 300. As a result, the rocker 508 begins torotate about the rocker axle 510, such that the distal arm 518 movesdownward and the proximal arm 514 of the rocker 508 moves upward. As thetrigger 308 is depressed, the distal end 520 of the distal arm 518 movesdownward. The stops 596 of the holder 594 continue to hold the distalslider 534 substantially in place against the proximal bias exerted bythe spring 540. Thus, the distal slider 534 does not substantially moveas the trigger 308 is initially depressed. The contact surface 548 ofthe distal slider 534 is curved to substantially match the travel of thedistal end 520 of the distal arm 518. That is, the radius of curvatureof the contact surface 548 relative to the rocker axle 510 issubstantially the same as the path of motion of the distal end 520 ofthe distal arm 518 as the rocker 508 rotates, and thus does notsubstantially interfere with the motion of the distal arm 518. If theholder 594 is not used, the distal end 520 of the distal arm 518 holdsthe distal slider 534 in substantially the same position as the distalarm 518 moves relative to the contact surface 548, due to the matchbetween the curvature of the contact surface 548 and the motion of thedistal end 520 of the distal arm 518. Alternately, the contact surface548 is configured differently. Further, the distal slider 534 may beconfigured to move as the trigger 308 is initially depressed, ifdesired.

The proximal end 516 of the proximal arm 514 moves upward as the trigger308 is depressed, and contacts the lower portion 530 of the contactfeature 528 of the proximal slider 522 if it is not initially in contactwith the proximal slider 522. As the proximal end 516 of the proximalarm 514 continues to move upward, it continues to engage the lowerportion 530 of the contact feature 528 of the proximal slider 522. Thelower portion 530 of the contact feature 528 is shaped such that acomponent of force exerted by the proximal end 516 of the proximal arm514 on that lower surface 530 is converted into a substantiallytranslational force acting on the proximal slider 522 to urge itproximally. As one example, the lower portion 530 of the contact feature528 is angled proximally and downward. Further, the ribs 526 andcorresponding flanges 524 of the proximal slider 522 substantiallylinearly constrain the motion of the proximal slider. The angle of thelower surface 530 relative to the arcuate motion of the proximal end 516of the proximal arm 514 results in the conversion of the substantiallyarcuate motion of the proximal end 516 of the proximal arm 514 tosubstantially linear motion of the proximal slider 522.

Thus, the upward motion of the rocker 508 against the lower portion 530of the contact feature 528 of the proximal slider 522 urges the proximalslider 522 in the proximal direction, against the bias of the spring 546connected to the proximal slider 522 and the handle 302. Referring alsoto FIG. 77, this is time t=1, the proximal slider 522 has movedproximally from time t=0, and the distal slider 534 has remained insubstantially the same position it occupied at time t=0. As the proximalslider 522 moves proximally, it takes up slack in the first cable orcables 480 connected thereto, if slack is present. The first cable orcables 480 are fixed to the anvil 10. Because the anvil 10 is in turnfixed relative to the shaft 304, the proximal motion of the first cableor cables 480 removes slack from, then tensions, the first cable orcables 480. The first cable or cables 480 pass through at least aportion of the cable housing 306. As described above, the cable housing306 curves between the shaft 304 and the tissue effector 400. Thetension in the first cable or cables 480 causes the cable housing 306 tomove. That is, the tension in the first cable or cables 480 acts uponthe flexible cable housing 306, causing its curvature to decrease.Although the cable housing 306 is at least partially flexible, the cablehousing 306 possesses stiffness longitudinally. Thus, as the curvatureof the cable housing 306 decreases, the distal end of the cable housing306 moves distally. Referring also to FIG. 58, the staple holder 38 isbiased away from the anvil 10 by a biasing element 475, which tends tomove the tissue effector 400 to an open position. The biasing element475 may be a coil spring, leaf spring, or any other structure ormechanism capable of applying a biasing force. When the tension in thefirst cable or cables 480 causes the distal end of the cable housing 306to move distally, the distal end of the cable housing 306 exerts a forceon the anvil 10 that overcomes the bias of the biasing element 475,causing the anvil 10 to rotate about a pivot point such as the pin 226to a standby position. In this way, the anvil arm 14 remainssubstantially stationary within the target vessel 580, while the stapleholder 38 rotates.

Alternately, where the tissue effector 400 of FIG. 154 is used, tensionis applied to the first cable 480. This tension may be applied by anysuitable mechanism in the handle 302, such as the spring-actuatedmechanism of FIG. 70, the gas-actuated mechanism of FIGS. 148-153, orany other suitable mechanism configured to move the tissue effector 400from an open position to a closed position and to deploy at least oneconnector from the tissue effector 400. The first cable 480 is routedthrough at least part of the anvil 10 and then upward to the stapleholder 38, to which it is connected. The axle 1082 directs the firstcable 480 upward to the staple holder 38. Advantageously, the axle 1082is located at a position in the anvil 10 that remains outside the lumenof the target vessel 580. As tension is applied to the first cable 480,moving it proximally, the axle 1082 changes the direction of the motionof the first cable 480 such that it pulls the staple holder 38 towardthe anvil 10. The staple holder 38 thus rotates about a pivot point suchas the pin 226 until reaching the closed position. In this way, theanvil arm 14 remains substantially stationary within the target vessel580, while the staple holder 38 rotates. Alternately, the staple holder38 and anvil 10 may be actuated to move between the position shown inFIG. 34 and the position shown in FIG. 44 by any structure, mechanism ormethod.

Alternately, a second cable housing (not shown) is provided. If so, thefirst cable or cables 480 may extend through the cable housing 306 asdescribed above, and the second cable or cables 490 may extend throughthe second cable housing. In this way, the forces exerted along thefirst cable or cables 480 and cable housing 306 are substantiallyisolated from the forces acting along the second cable or cables 490 andthe second cable housing.

Referring also to FIGS. 29-31, 44 and 76, as the staple holder 38 andanvil 10 move closer together, the staple holder 38 holds a root 405 ofeach flap 408 against or in proximity to the outer surface of the targetvessel 580. For clarity, the flaps and graft vessel are not shown inFIG. 44. That is, the roots 405 of the flaps 408 are apposed to theouter wall of the target vessel 580. As a result, a portion of theintimal layer of the graft vessel 404 at the root 405 of each flap 408is placed against the outer wall of the target vessel 580. The flaps 408are held by the staple holder 38 in a substantially fixed positionrelative to the surface of the target vessel 580, such that the end ofthe graft vessel 404 is substantially immobile relative to the wall ofthe target vessel 580. Thus, the position of the end of the graft vessel404 relative to the wall of the target vessel 580 remains substantiallyunchanged throughout the duration of the anastomosis procedure. Further,after the anvil arm 14 has been inserted into the lumen of the targetvessel 580, the contact surface 206 of the anvil arm 14 is substantiallyin contact with the inner surface of the wall of the target vessel 580.The perimeter of the end of the graft vessel 404 defines a closed areaon the wall of the target vessel. The location of a connection madebetween the end of the graft vessel 404 and the wall of the targetvessel is substantially registered with an opening made within theclosed area in the wall of the target vessel, regardless of the order inwhich the connection and the opening are made. Further, the position ofthe end of the graft vessel 404 relative to the wall of the targetvessel 580 substantially maintains position registration throughout theduration of the anastomosis procedure relative to the opening in thewall of the target vessel through which the anvil arm 14 is inserted.

As the staple holder 38 and anvil 10 move together, the engagementmember 216 engages the receiver 218. As described above, the receiver218 may be defined in the sled 482. However, the receiver 218 may be aseparate component from the sled 482. Alternately, when the tissueeffector 400 is in the closed position, the engagement member 216 of thecutter 200 or the cutter slide 1092 does not engage the receiver 218.Instead, the engagement member 216 and the receiver 218 are positionedrelative to one another such that motion of the receiver 218 as a resultof motion of the second cable 490, as described below, brings theengagement member 216 and the receiver 218 into contact such that theengagement member 216 is placed into motion as well. Further, if theoptional safety feature 210 is utilized, the relative motion of thestaple holder 38 and the anvil 10 causes the staple holder 38 to contactthe safety feature 210 and urge it downward against its upward bias.Consequently, the tip 212 of the safety feature 210 is moved downwardout of engagement with the safety recess 214 of the cutter 200.Alternately, another structure or mechanism is configured to engage thesafety feature 210 when the staple holder 38 and anvil 10 are movedtogether, so as to urge the tip 212 out of the safety recess 214. Thus,in the standby position, the cutter 200 is freed for translation alongthe channel 246.

Optionally, an interface structure 238 may be connected to or formedinto the staple holder 38. The interface structure 238 engages the anvil10 or a component associated with the anvil 10 as the staple holder 38and the anvil 10 move to the standby position, such as by snapping ontoa corresponding feature (not shown) on the anvil 10. By doing so, theinterface structure 238 holds the staple holder 38 substantially fixedrelative to the anvil 10, in order to maintain registration between thetarget vessel, the graft vessel, the anvil 10 and the staple holder 38.The interface structure 238 may be a tab, rail, bump, or any otherfeature that is capable of engaging a corresponding feature and holdingthe staple holder 38 substantially fixed relative to the anvil 10.Alternately, the interface structure 238 is formed into or connected tothe anvil 10 and engages a corresponding feature on the staple holder38.

Referring also to FIG. 95, as the staple holder 38 and the anvil 10 movetoward the closed position the shield 290 remains outside the targetvessel 580, between the end of the graft vessel 404 and the outersurface of the target vessel 580. As the staple holder 38 presses theflaps 408 against the outer surface of the target vessel 580, the flaps408 and/or the graft vessel 404 contact the shield 290 and press ittoward the outer surface of the target vessel 580. The proximal element292 and the second ramp element 295 of the shield 292 are thus pressedinto substantial contact with the outer surface of the target vessel580. At least part of the anvil arm 14 is in contact with thecorresponding inner surface of the target vessel 580, providing supportfor the shield 290. Contact between the second ramp element 295 of theshield 290 and the outer surface of the target vessel 580 supports theraised element 293 and holds the raised element 293 spaced apart fromthe outer surface of the target vessel 580. Alternately, the proximalelement 292 and/or the second ramp element 295 of the shield 290 movetoward the target vessel 580 but are not pressed into substantialcontact with the target vessel 580. Alternately, one or more differentor additional parts of the shield 290 are pressed into contact with theouter surface of the target vessel 580. The raised element 293 holds aportion of the tissue of the graft vessel 404 apart from the outersurface of the target vessel 580. Further, the raised element 293substantially prevents contact between the cutter 200 and the tissue ofthe target vessel 580, as described in greater detail below. The shield290 and the aperture 296 in the shield are substantially aligned withthe anvil arm 14 both before and after the staple holder 38 and theanvil 10 have moved to a closed position relative to one another.Referring also to FIGS. 106 and 144-145, where the shield 290 isconnected to the staple holder 38 instead of the anvil 10, as the stapleholder 38 and the anvil 10 move toward the closed position the shield290 remains outside the target vessel 580, between the end of the graftvessel 404 and the outer surface of the target vessel 580. At least partof the shield 290 may contact the outer surface of the target vessel 580when the tissue effector 400 is in the closed position. Where the shield290 is connected to the staple holder 38, it may be sized andconfigured, and may act, in substantially the same manner as if it wereconnected to the anvil 10.

Where the graft affixer 910 is utilized, it may be movable from a firstposition when the tissue effector 400 is in the open position to asecond position when the tissue effector 400 is in the closed position.Referring also to FIG. 131, if the graft affixer 910 is movable relativeto the staple holder 38, it initially occupies a first position relativeto the staple holder 38. In the first position, the graft affixer 910extends a first distance outward from the staple holder 38 thatfacilitates penetration of the flap 408. Referring also to FIG. 132, asthe anvil 10 and staple holder 38 move closer to one another toward theclosed position, the anvil 10 contacts the base 914 of the graft affixerassembly 912 and exerts force on it. This force urges the graft affixerassembly 912 away from the anvil 10. This force may act against africtional force resulting from the friction fit of the base 914 withthe aperture 918, or against a biasing force that biases the graftaffixer assembly 912 to the first position. The aperture 918 may act toguide the motion of graft affixer assembly in a substantially linearmanner. As the graft affixer assembly 912 moves away from the anvil 10,the graft affixer 910 moves relative to the staple holder 38 such thatit extends a second distance outward from the staple holder 38 that isless than the first distance, but that is still sufficient to hold thegraft vessel 404. Further, the graft affixer 910 thus does not interferesubstantially with the anvil 10 when the graft affixer 910 is in thesecond position. As the anvil 10 and the staple holder 38 reach theclosed position, the graft affixer 910 may penetrate the tissue of thetarget vessel 580 at least partially. Alternately, the base 914 of thegraft affixer assembly 912 does not substantially move as the tissueeffector 400 moves from the open position to the closed position, andcontact between the anvil 10 and the graft affixer 910 causes the graftaffixer 910 to slide, deform or otherwise transition from its firstdistance outward from the staple holder 38 to its second distanceoutward from the staple holder 38.

Where the graft affixer 910 is the heel clip 910 of FIG. 158, the tissueeffector 400 also moves from the open position to the closed position asdescribed above. As the staple holder 38 moves closer to the anvil 10,the free end 1152 penetrates completely through the wall of the targetvessel 580. Alternately, an arteriotomy or other opening has alreadybeen formed in the target vessel 580, and the free end 1152 of the leg1150 enters the target vessel 580 through that opening withoutpenetrating the wall of the target vessel 580.

As the staple holder 38 moves closer to the anvil 10, the free end 1152of the leg 1150 contacts the anvil 10. A bending feature (not shown) maybe formed in the anvil 10 such that the free end 1152 of the leg 1150contacts the bending feature upon contacting the anvil 10. Additionally,or instead, the leg 1150 may be curved in proximity to its free end1152. The leg 1150 begins to deflect as it is pressed into contact withthe anvil 10 by motion of the staple holder 38, where such deflectionmay be assisted by the bending feature and/or the curvature of the leg1150. As the movement of the tissue effector 400 to the closed positionexerts force on the heel clip 910, the heel clip 910 continues to beheld by the staple holder, such as by engagement between the first tab1154 and the ledge 1164, the second tab 1158 and the notch 1164, and/orthe base 1156 and the pocket 1157. As the tissue effector 400 continuesto move to the closed position, the heel clip 910 continues to bend.This bending may occur at the junction between the base 1156 and the leg1150 and/or at one or more locations along the leg 1150. The junctionbetween the base 1156 and the leg 1150 may be sized and/or shaped toconcentrate bending at that junction, if desired. Further, as the tissueeffector 400 continues to move to the closed position, the free end 1162of the prong 1160 contacts and then penetrates the outer surface of thetarget vessel 580. The free end 1162 may penetrate partially orcompletely through the wall of the target vessel.

When the tissue effector 400 has reached the closed position, referringto FIGS. 159-160, the heel clip 910 is in a closed position. The leg1152 has been bent such that its free end 1152 may be oriented at leastpartially upward. Further, the free end 1152 of the leg 1150 maypenetrate into the wall of the target vessel 580 either partially orcompletely when the heel clip 910 is in the closed position. In theclosed position, tissue of the target vessel 580 is compressed betweenthe leg 1150 and the base 1156 of the heel clip 910. Further, the heelclip 910 may engage the tissue of the target vessel 580 by penetrationby the free end 1152 of the leg 1150 and/or the free end 1162 of theprong 1160, thereby providing additional security. As the heel clip 910moves to the closed position, the first tab 1152 moves inward as the leg1150 is bent. When the heel clip 910 is in the closed position, thefirst tab 1152 has moved inward enough such that the first tab 1152 nolonger engages the ledge 1162. In this way, the heel clip 910 is freedfrom the staple holder 38, such that the heel clip 910 is detached fromthe staple holder 38 upon its deformation to the closed position.

Alternately, the staple holder 38 may be constructed to deploy aplurality of heel clips 910 around the perimeter of the anastomosis, inlieu of staples or other connectors 464. In this way, construction ofthe tissue effector 400 may be greatly simplified. That is, the sled482, the connector bays 448, the connector deployers 452, and/or othercomponents of the staple holder 38 may be simplified or omitted.Instead, a plurality of heel clips 910 may be detachably connected tothe staple holder 38 in the locations that would otherwise be occupiedby the connector bays 448. Graft preparation proceeds substantially asdescribed above, with the exception that the flaps 408 would be pusheddown onto the leg 1150 of each heel clip 910. Alternately, no flaps 408are incised in the graft vessel 404, and an end of the graft vessel 404is everted onto and pushed down onto the legs 1150 of the heel clips910. Deployment of the heel clips 910 to connect the graft vessel 404 tothe target vessel 580 is performed by deformation of the heel clips 910,as described above. By placing the heel clips 910 at the locationscorresponding to those at which the connectors boys 448 would haveplaced the connectors 464, the tissue effector 400 completes theanastomosis.

Referring also to FIG. 70, the user continues to depress the trigger308. As a result, the rocker 508 continues to rotate about the rockeraxle 510 such that the distal end 520 of the distal arm 518 continues tomove downward, and the proximal end 516 of the proximal arm 514continues to move upward. As the proximal end 516 of the proximal arm514 continues to move upward, its contact with the lower portion 530 ofthe contact feature 528 of the proximal slider 522 continues to urge theproximal slider 522 proximally. When the proximal end 516 of theproximal arm 514 has reached a position at or near the intersectionbetween the two portions 530, 532 of the contact feature 528, theproximal slider 522 has moved substantially as far proximally as it willmove during actuation of the anastomosis tool 300. Further, when theproximal end 516 of the proximal arm 514 has reached that position, thestaple holder 38 and the anvil arm 14 are still in the standby position.Referring also to FIG. 77, this is time t=2, at which the proximalslider 522 has moved proximally from its position at time t=1, and hasreached its most proximal position. The distal slider 534 is insubstantially the same position that it was in at time t=1.

Operation of Anastomosis Tool—Deploying Connectors

The user continues to depress the trigger 308. As the proximal end 516of the proximal arm 514 continues to move upward, it moves past theintersection between the two portions 530, 532 of the contact feature528, thereby contacting the upper portion 532 of the contact feature528. The upper portion 532 of the contact feature 528 providessubstantially no resistance to the continued rotation of the rocker 508,because it is substantially vertical or angled in a proximal directionas it extends upward. The proximal end 516 of the proximal arm 514 thusmoves upward rapidly. Alternately, the speed of the motion of theproximal end 516 of the proximal arm 514 is controlled to be the same asor slower than its speed while it contacts the lower portion 530 of thecontact feature 528. During the upward motion of the proximal end 516 ofthe proximal arm 514, the proximal slider 522 may move distally at leastslightly due to the arcuate motion of the proximal end 516 of theproximal arm 514 relative to the non-arcuate upper portion 532 of thecontact feature 528.

As the proximal end 516 of the proximal arm 514 moves upward along theupper portion 532 of the contact feature 528, the distal end 520 of thedistal arm 518 continues to move downward along the contact surface 548of the distal slider 534. As described above, the posts 544 at thedistal end 520 of the distal arm 518 are spaced apart from one another,such that a gap is present between them. The distal arm 518 may contactthe contact surface 548 via the posts 544 during at least a portion ofits travel. As the distal end 520 of the distal arm 518 moves downward,the posts 544 reach the bottom edge 570 of the contact surface 548. Therocker 508, the proximal slider, and the distal slider 534 arepositioned relative to one another and shaped such that the posts 544reach the bottom edge 570 of the contact surface 548 at substantiallythe same time that the proximal end 516 of the proximal arm 514 reachesthe intersection between the two portions 530, 532 of the contactfeature 528 of the proximal slider 522.

Referring also to FIG. 78, when the posts 544 reach the bottom edge 570of the contact surface 548, they contact the members 600 of the holder594. As the distal end 520 of the distal arm 518 continues to movedownward, the posts 544 thereby press the members 600 downward. As aresult, the stops 596 are moved out of engagement with the bottom edge570 of the contact surface 548, such that the stops 596 no longercontact the distal slider 534. Consequently, the stops 596 no longerrestrain the distal slider 534 against proximal motion under theinfluence of the spring 540. The width of the lower guide 552 is lessthan the width of the gap between the posts 544, and the lower guide 552is substantially aligned with the gap between the posts 544. Thus, afterthe stops 596 have been pushed below the bottom edge 570 of the contactsurface 548 of the distal slider 534, the lower guide 552 is free toslide through the gap between the posts 544 and through the proximal endof the holder 594. The proximal motion of the distal slider 534 thustakes up the slack (if any) in the second cable 490 connected to thedistal slider 534, then causes that second cable 490 to move proximally.Referring also to FIG. 77, this is time t=3, at which the distal slider534 has rapidly moved proximally from its position at time t=2, and theproximal slider 522 has moved slightly in the distal direction from itsposition at time t=2.

Referring also to FIG. 58, this proximal motion of the second cable 490urges the sled 482, which also is connected to the second cable 490,into motion. As described above, at least one channel 496 is defined inthe staple holder 38, and the second cable 490 is guided by acorresponding channel 496. The staple holder 38 is shaped such that thechannel 496 curves and causes the second cable 490 to curve back in aproximal direction. The second cable 490 is connected to the sled 482.Thus, the curvature of the channel 496 causes the second cable 490 tocurve, such that the proximal motion of the second cable 490 pulls thesled 482 distally. In this way, proximal motion of the distal slider 534causes the sled 482 to move distally.

Referring also to FIGS. 64 and 68-69, the sled 482 includes one or moreramp elements 446, each movable within a corresponding passage 440 in anarm 402 of the staple holder 38, as described above. Initially, the sled482 is positioned such that each ramp element 446 is proximal to themost proximal connector bay 448 connected to the corresponding passage440. Thus, as the second cable 490 is tensioned and moved proximally bythe distal slider 534, and the sled 482 moves distally as a result, eachramp element 446 moves distally in its corresponding passage 440.Alternately, the sled 482 is positioned initially such that each rampelement 446 is distal to the most distal connector bay 448. As thesecond cable 490 is tensioned and moved proximally, the second cablepulls each ramp element 446 proximally, deploying the connectors 464 ina similar manner but in the reverse order.

For convenience in describing the deployment of staples 464, the motionof one ramp element 446 through the corresponding passage 440 will bedescribed; the motion of each additional ramp element 446 through itscorresponding passage 440 occurs in the same or a similar manner.Referring to FIG. 64, as the ramp element 446 moves distally from itsinitial position, its distal end 474 contacts the most proximalconnector deployer 452. As described above, each connector deployer 452initially is in a first position in which its outer end 454 extends intothe passage 440. When the distal end 474 of the ramp element 446contacts the most proximal connector deployer 452, it urges thatconnector deployer 452 into the corresponding connector bay 448. Thedistal end 474 of the ramp element 446 may be shaped such that its innersurface 476 curves or angles relative to the direction of travel of theramp element 446. Thus, when the distal end 474 of the ramp element 446encounters the outer end 454 of the most proximal connector deployer452, a component of the force it exerts on the connector deployer 452 issubstantially parallel to the longitudinal centerline of thecorresponding connector bay 448. That centerline may be substantiallyperpendicular to the direction of travel of the ramp element 446, or maybe otherwise oriented relative to the direction of travel of the rampelement 446.

As a result of contact with the distal end 474 of the ramp element 446,the connector deployer 452 begins to move through the correspondingconnector bay 448, away from the passage 440. A connector 464 is locatedin the connector bay 448, inward from the connector deployer 452. Thetines 466 of the connector 464 initially may be biased against at leastpart of the corresponding connector bay 448 as described above, or theconnector 464 may otherwise be held within the connector bay 448 priorto motion of the connector deployer 452. As the connector deployer 452moves, it exerts a force on the corresponding connector 464, overcomingthe force with which the connector 464 is initially held in place andpushing the connector 464 inward. As the connector 464 is urged inward,the registration element 458 (if used) translates along the registrationfeature 462 of the connector bay 448. The registration element 458reduces or eliminates lateral cocking of the connector deployer 452during its translation through the connector bay 448, such that theconnector deployer 452 is maintained in substantially the sameorientation throughout its travel.

Referring also to FIG. 61 (in which the graft vessel and target vesselare not shown for clarity), as the connector deployer 452 urges theconnector 464 out of the connector bay 448, the tines 466 of theconnector 464 move out of the connector bay 448, penetrate the root 405of the flap 408 held against the inner surface 450 of the arm 402, thenpenetrate the wall of the target vessel 580. One or more of the arms 402may be angled relative to a horizontal plane to facilitate connectingthe flaps of the graft vessel 404 to the wall of the target vessel 580,where that angle is chosen to place connectors in a desired orientationrelative to the surface of the target vessel 580. Advantageously, thestaples 464 enter the target vessel substantially perpendicular to it.However, the staples 464 can enter the target vessel at a differentangle, and/or at different angles relative to one another.

After the tines 464 have completely penetrated the wall of the targetvessel, they encounter corresponding staple bending features 572 in theanvil arm 14. The staple bending features 572 are depressions in thesurface of the anvil arm 14, aligned with the connector bays 448 suchthat at least one tine 466 of at least one connector 464 encounters astaple bending feature 572 upon being pushed out of its connector bay448. One or more of the staple bending features 572 may be configureddifferently, or may be omitted altogether. As the connector deployer 452continues to urge the connector 464 out of the connector bay 448 andtoward the anvil arm 14, the tines 466 of the connector 464 are pressedinto the staple bending features 572. Thus, the force transmitted fromthe ramp element 446 to the connector deployer 452 presses the tines 466into the staple bending features 572, causing them to deflect. The tines466 may be deflected in any direction suitable for holding the flap 408to the graft vessel 404. Optionally, the staple bending features 572 maybe omitted. If so, the tines 466 simply engage the surface of the anvilarm 14. Alternately, where the connectors 464 are not staples, thestaple bending features 572 are not needed. For example, where theconnectors are clips, microrivets or other structures or mechanisms thatare not staples, the staple bending features 572 need not be provided.Alternately, where the connectors 464 are superelastic staplesconfigured to close without the need for contact with an anvil, thestaple bending features 572 need not be provided.

Where the most proximal connector bay 448 and/or the most distalconnector bay 448 in an arm 402 is offset toward the longitudinalcenterline of the anvil arm 14 relative to one or more other connectorbays 448, the connector deployer 452 in each offset connector bay 448 isactuated substantially as described above. The ramp element 446 maycontact each such connector deployer 452 at a location offset from thelongitudinal centerline of that connector deployer 452. As a result, theramp element 446 may contact less area of each offset connector deployer452 as compared to its contact with the other connector deployers 452.However, such contact is sufficient to urge each connector deployer 452along the corresponding offset connector bay 448 to deploy the connector464 in that connector bay 448. When the widest portion of the distal end474 of the ramp element 446 encounters the outer end 454 of theconnector deployer 452, the connector deployer 452 reaches the end ofits stroke through the connector bay. The connector 464 and thecorresponding staple bending feature or features 572 are configured suchthat the deflection of the tines 446, and thus the deployment of theconnector 464, is substantially complete when the correspondingconnector deployer 452 reaches the end of its stroke. The ramp element446 then continues its motion through the passage 440 to encounter thenext connector deployer 452, such that the staples 464 in each arm 402are deployed sequentially. Alternately, the ramp element 446 and passage440 are configured such that the ramp element 446 moves in substantiallythe same direction as the connector deployers 452, or is otherwiseconnected to the connector deployers 452, such that two or more of theconnector deployers 452 are actuated substantially simultaneously. Thatis, the connector deployers 452 may be actuated in series, in parallel,or in a different way. For example, the connector deployers 452 may beselectively actuated, such that a selected number of staples 464 can bedeployed. The user can deploy a selected number of staples 464 based onthe size of the graft vessel 404 or other relevant factors. That is, thestaple line (the length along the target vessel 580 along which staples464 are deployed) is adjustable. Such adjustment may be performed in anyappropriate manner, such as by adjusting the distance traveled by eachramp element 446 during deployment of the staples 464. Alternately,other mechanisms or structures may be used to deploy the staples 464from the connector bays 448 in a desired sequence.

As described above, the staple holder 38 includes two spaced-apart arms402. A ramp element 446 proceeds distally through a correspondingpassage 440 in each arm 402. Further, the connector bays 448 in each arm402 are aligned in a substantially bilaterally symmetric manner. Thus,as the sled 482 translates distally, the distal end 474 of each rampelement 446 encounters a connector deployer 452 at substantially thesame time, such that a connector 464 is deployed from each arm 402 atsubstantially the same time. As a result, the staple holder 38sequentially deploys pairs of staples 446 into tissue as the rampelements 446 move distally. Alternately, the connector bays 448 arestaggered, such that staples 464 from each arm 402 are deployed atdifferent times than staples from the other arm 402.

Optionally, the sled 482 also includes vein knives 432. Each vein knife432 translates through a corresponding vein knife passage 430 defined bya first channel 426 in the graft clip 412 and a second channel 428 inthe flap receiving surface 406, as described above. The distal end 434of each vein knife 432 is sharp, and may be a blade 434. As describedabove, the vein knives 432 are initially in a first position, where thedistal end 434 of each vein knife 432 is located proximal to the root405 of the corresponding flap 408. As the second cable 490 is tensionedand pulled toward the handle 302 by the distal slider 534, the sled 482moves distally. The vein knives 432, which are connected to the sled 482move distally as well through the corresponding vein knife passages 430.

As each vein knife 432 moves distally, its sharp distal end 434 engagesthe proximal edge of the root 405 of the corresponding flap 408,entering the tissue of the flap 408 and beginning to make an incisiontherein. The serrations 438 on the graft clip blades 436 assist inholding the flap 408 as the corresponding vein knife 432 incises it.Alternately, those serrations 438 may assist in incising the flap 408,depending on their configuration. In addition, the serrations 438 mayassist in holding the excess tissue incised from each flap 408, afterthe vein knife 432 has made an incision through the entire flap. Thevein knives 432 do not extend as far in the distal direction as the rampelements 446. Thus, as the sled 482 translates distally, the distal end474 of each ramp element 466 reaches any given longitudinal positionbefore the blade 434 of the corresponding vein knife 432. Consequently,the ramp element 466 causes a staple 446 to deploy at a particularlongitudinal position before the corresponding vein knife 432 extendsthe incision in the flap 408 to that longitudinal position. By staplingbefore incising at any given longitudinal position, each flap 408 isheld securely as it is cut by the corresponding vein knife 432.Alternately, at any given longitudinal position, the flap 408 is incisedduring or before deployment of a staple 446 at that position. Each veinknife 432 is positioned to cut the flap 408 far enough from the deployedstaples 446 to minimize or eliminate interference with these staples446, but close enough to the staples 446 to cut away excess tissue onthe flap 408 that is not needed for the finished anastomosis.

Operation of Anastomosis Tool—Creating Opening in Target Vessel

Referring also to FIGS. 45, 58 and 68, the cutter 200 has been freed fortranslation. The cutter 200 is urged distally by the receiver 218, whichengages the engagement feature 216 of the cutter 200. The receiver 218may be defined in the sled 482, as described above. As the sled 482 ispulled distally by the second cable 490, the receiver 218 movesdistally, thereby urging the engagement feature 216 of the cutter 200distally. Alternately, the receiver 218 is not defined in the sled 482.Instead, the receiver 218 is a separate structure that may be connectedto the sled 482, and that is configured to travel along a guidestructure 241. The guide structure 241 is a rail or other structurealong which the receiver 218 slide, and the receiver 218 interfaces withand translates along the rail. Thus, the guide structure 241 guides thetranslation of the receiver 218. A cavity 240 is provided in the stapleholder 38 adjacent to the guide structure 241 to allow for motion of thereceiver 218 along the guide structure 241. The cavity 240 is sized toallow the receiver 218 to translate freely. Alternately, the guidestructure 241 is a hollow channel defined within the staple holder 38,such that the walls of the channel guide the translation of the receiver218. Alternately, the guide structure 241 may be any other structure ormechanism capable of guiding the translation of the receiver 218. Theguide structure 241 is substantially aligned with the anvil arm 14. Thatis, the longitudinal centerline of the guide structure 241 issubstantially parallel to the longitudinal centerline of the anvil arm14. Thus, motion of the receiver 218 along the guide structure 241causes translation of the engagement feature 216 and thereforetranslation of the cutter 200 substantially parallel to the centerlineof the anvil arm 14. The receiver 218 may be actuated to translate alongthe guide structure 241 by the second cable 490, which transmits forcefrom the handle 302. Alternately, the actuator may convert stored energyto force that is applied to the cutter. Such stored energy may beprovided by a spring, battery, source of compressed gas, or othersource. Alternately, any mechanism, structure or method, using storedenergy or not, may be used to translate the receiver 218 along the guidestructure 241. The particular mechanism, structure or method used tocause translation of the cutter 200 is not critical to the invention.

The upper surface 252 of the cutter 200 is substantially planar proximalto the projection 208. The biasing element 260 contacts the uppersurface 252 of the cutter 200 and biases the cutter 200 downward. Thecutter 200 includes a keel 264 that extends downward. The keel 264 maybe formed into the cutter 200, or may be a separate component connectedto the cutter 200. The keel 264 is substantially as wide as the adjacentportion of the cutter 200. However, the keel 264 may be wider ornarrower than the adjacent portion of the cutter 200. The keel 264 ispositioned at or near the distal end of the cutter 200. Alternately, thekeel 264 may be positioned at a different location on the cutter 200.

Referring to FIG. 43A, another embodiment of a cutter 200 is shown. Asdescribed above, the cutter 200 includes at least one projection 208extending substantially upward from a position at or near its distalend, and an engagement feature 216 extending upward from the uppersurface 252 of the cutter 200. In this embodiment, the keel 264 of thecutter 200 is spaced apart from the projection 208, differing from theembodiment of FIG. 37-38 in which the keel 264 is adjacent to theprojection 208. By spacing the keel 264 apart from the projection 208,the keel 264 can project a smaller distance downward while moving theprojection 208 substantially the same amount upward and downward.Consequently, the keel 264 as a whole can be made smaller.

Referring to FIG. 43B, another embodiment of a cutter 200 is shown. Asdescribed above, the cutter 200 includes at least one projection 208extending substantially upward from a position at or near its distalend, and an engagement feature 216 extending upward from the uppersurface 252 of the cutter 200. In this embodiment, the cutter 200includes a first keel 264 and a second keel 265. The first keel 264 maybe configured similarly to the keel 264 of FIG. 43, and the second keel265 may be configured similarly to the keel 265 of FIG. 43A. The firstkeel 264 extends further below the body of the cutter 200 than thesecond keel 265. A third lower opening (not shown) is defined through alower surface 256 of the anvil 10, in addition to the first loweropening 254 and the second lower opening 268. The third lower opening isspaced apart from the second lower opening 268, and is positioned distalto the second lower opening 268. The first keel 264 initially extendsinto the second lower opening 268, and the second keel 265 initiallyextends into the first lower opening 254.

As shown in FIG. 45, the keel 264 initially extends into the first loweropening 254, which is defined through a lower surface 256 of the anvil10. The keel 264 may extend completely through the first lower opening254, such that its lowest point extends outside the anvil 10. The keel264 is biased downward into the first lower opening 254 as a result ofthe downward force exerted on the cutter 200 by the biasing element 260.While the keel 264 is biased into the first lower opening 254, theprojection 208 remains below the contact surface 206 of the anvil arm14. In this way, the projection 208 does not extend out of the anvil arm14 while the anvil arm 14 is inserted into the wall of a target vessel.Where the cutter 200 of FIG. 43A is used, the keel 264 need not extendinto or through the first lower opening 254 as far as the keel 264 ofthe cutter 200 of FIGS. 37-38. As a result, less clearance for themotion of the keel 264 need be provided, and the tissue effector 400 maybe made more compact. The first lower opening 254 extends along a fixedlength of the lower surface 256 of the anvil 10. As the cutter 200translates distally, the keel 264 continues to remain at least partiallywithin the first lower opening 254, such that the projection 208continues to remain below the contact surface 206 of the anvil arm 14.Initially, the keel 264 may be positioned proximal to the distal end ofthe first lower opening 254. The length of the first lower opening 254is selected to cause the projection 208 to remain below the contactsurface 206 of the anvil arm 14 across that distance. That is, thisdistance is selected such that the projection 208 on the cutter 200 doesnot engage the wall of the target vessel until the projection 208 ispositioned within the circumference of the graft vessel. That is, theconnection between the graft vessel and the target vessel substantiallydefines a closed area, and the projection 208 is configured to engagethe wall of the target vessel within that closed area. In this way, theprojection 208 makes an incision completely within the connectionbetween the graft vessel and the target vessel, completing theanastomosis between the two vessels and minimizing or eliminatingleakage at the anastomosis site. While the projection 208 on the cutter200 remains below the upper surface of the anvil arm 14, it neitherengages nor cuts the wall of the target vessel.

Referring also to FIG. 46, the cutter 200 continues to advance distallyas the receiver 218 continues to urge the engagement feature 216distally. As described above, at least the distal end of the cutter 200is biased downward. As the cutter 200 advances distally, the keel 264encounters the distal end of the first lower opening 254. Thisencounter, and the continued proximal translation of the cutter 200,causes the keel 264 to move upward relative to the anvil arm 14. Thekeel 264 and/or the distal end of the first lower opening 254 may beconstructed to provide a smooth, gradual upward motion of the keel 264,such as by providing a gradual slope on the keel 264 and/or the distalend of the first lower opening 254. Alternately, the keel 264 and/or thedistal end of the first lower opening 254 may be constructed to allow orcause the keel 264 to move upward abruptly upon encountering the distalend of the first lower opening 254. The upward motion of the keel 264causes the distal end of the cutter 200 and the projection 208 to moveupward. Thus, the size and position of the first lower opening 254,including the position of the distal end of the first lower opening 254,control the motion of the cutter 200 and the projection 208 in thevertical direction.

Where the cutter 200 of FIG. 43A is used, the keel 264 contacts thedistal end of the first lower opening 254 in the same manner as thecutter of FIGS. 37-38. By spacing the keel 264 apart from the projection208, the projection 208 may be protected from inadvertent contact withthe distal end of the first lower opening 254. The initial position ofthe cutter 200 relative to the remainder of the tissue effector 400 maybe different than that of the cutter 200 of FIGS. 37-38, to ensure thatthe projection 208 enters the wall of the target vessel at a selectedpoint relative to the tissue effector 400. Where the cutter 200 of FIG.43B is used, as the cutter 200 is urged distally, the second keel 265and the first lower opening 254 are configured such that the second keel265 contacts the distal end of the first lower opening 254 before thefirst keel 264 can contact the distal end of the second lower opening268. In this way, the distal end of the cutter 200 is prevented fromcontacting the distal end of the second lower opening 268.

As the distal end of the cutter 200 moves upward, the projection 208moves upward through the upper opening 248 in the anvil arm 14. Thecontact surface 206 of the anvil arm 14 is substantially adjacent to theinner surface of the wall of the target vessel. Thus, upward motion ofthe projection 208 through the upper opening 248 and above the contactsurface 206 of the anvil arm 14 causes the projection 208 to enter thewall of the target vessel. The cutter 200 continues to move distally,such that the keel 264 moves out of the first lower opening 254completely and contacts the bottom surface 266 of the channel 246 of theanvil arm 14. The projection 208 is sized such that the projection 208completely penetrates the wall of the target vessel when the keel 264has moved proximally to the first lower opening 254 and is in contactwith the bottom surface 266 of the channel 246. That is, at least aportion of the projection 208 passes through the wall of the targetvessel and enters the lumen of the target vessel. This initialpenetration of the wall of the target vessel defines the starting pointof an arteriotomy performed on the target vessel by the projection 208.The starting point of the arteriotomy is spaced apart from the locationon the target vessel at which the anvil arm 14 is inserted, because thecutter 200 and the projection 208 have moved proximally a selecteddistance before penetrating or incising the wall of the target vessel.The insertion point of the anvil arm 14 into the target vessel may bereferred to as the anvil entry hole 584 or the anvil insertion point.The portion of the wall of the target vessel between the arteriotomy andthe insertion point of the anvil arm 14 may be referred to as a tissuebridge. The incision is referred to as an arteriotomy for convenience,and this terminology does not limit the type of anastomosis that may beperformed. For example, anastomosis may be performed between two tissuestructures that are not blood vessels, such as bile ducts. The anvilentry hole 584 may be upstream from the arteriotomy, meaning that theanvil entry hole 584 is spaced apart from the arteriotomy in thedirection opposite to the direction of fluid flow within the targetvessel 580. Alternately, the anvil entry hole 584 may be downstream fromthe arteriotomy, meaning that the anvil entry hole 584 is spaced apartfrom the arteriotomy in the same direction as the direction of fluidflow within the target vessel 580.

The projection 208 of the cutter 200 enters the wall of the targetvessel at a location between the arms 402 of the staple holder 38. Eacharm 402 holds at least a portion of a flap 408 of the graft vessel 404against the wall of the target vessel, such that the projection 208enters the wall of the target vessel at a location between the flaps408. The length of the cutter 200, the position of the projection 208 onthe cutter 200, and the placement of the first lower opening 254 may beselected such that the projection 208 enters the wall of the targetvessel after at least one staple 446 is deployed into one of the flaps408 and the wall of the target vessel. Alternately, the projection 208enters the wall of the target vessel before any of the staples 446 havebeen deployed, or after all of the staples 446 have been deployed.Further, the length of the cutter 200, the position of the projection208 on the cutter 200, and the placement of the first lower opening 254may be selected such that the projection enters the wall of the targetvessel at substantially the same time that one or more vein knives 432begin to incise the corresponding flaps 408.

Where the cutter 200 of FIGS. 115-118 is used, the cutter 200 initiallyis in the stowed position, in which it is substantially restrained fromtranslation. Referring to FIG. 115, the spring 852 presses the pusher850 against the bottom surface 266 of the channel 246 in the anvil arm14, substantially restraining the pusher 850 and the remainder of thecutter 200 from translation. The button 854 is positioned relative tothe spring 852 such that it compresses the spring 852 when the cutter200 is in the stowed position. Alternately, any other suitablestructure, mechanism or method may be used to restrain the cutter 200.

Referring also to FIG. 116, the pusher 850 remains substantiallyrestrained against translation, and the member 848 is moved proximally.This motion of the member 848 exerts a force in the proximal directionon the projection 208, causing the projection 208 to move in theproximal direction. As the projection 208 moves, it encounters thesubstantially stationary pusher 850. The distal end of the pusher 850may be beveled or otherwise shaped such that at least the upper portionof that distal end is angled or curved proximally, as described above.The end 866 of the projection 208 initially faces at least partiallyproximally, and is initially against or in proximity to the distal endof the pusher 850. The angle or curvature of the distal end of thepusher 850 allows the end 866 of the projection 208 to slide onto thatdistal end of the pusher 850, moving upward as it does so. Because themember 848 is connected to the projection 208 at a location beneath thelongitudinal centerline of the pusher 850, such motion of the end 866 ofthe projection 208 is facilitated. As the end 866 of the projection 208moves upward, it moves above the contact surface 206 of the anvil arm14, and continues to move upward into the wall of the target vessel 580.Initially, the edge 209 of the projection 208 is oriented substantiallyupward. The edge 209 extends substantially to the end 866 of theprojection 208, which is the part of the projection 208 that encountersthe tissue of the target vessel 580. Alternately, the edge 209 ispositioned or configured differently. As the end 866 of the projection208 moves upward, the edge 209 incises the wall of the target vessel580, causing the projection 208 to cut through the target vessel wall580. The cutter 200 is now in the active position, with the projection208 extending through the wall of the target vessel 580 and the edge 209of the projection 208 oriented in the direction in which the projection208 is to be moved, which as shown is the distal direction. The button854 is moved distally such that it no longer compresses the spring 852.The pusher 850 is thus no longer compressed against the bottom surface266 of the channel 246 and is therefore free to translate within thechannel 246, and the cutter 200 is thereby freed.

Referring also to FIG. 117, the pusher 850 is then urged distally in anyappropriate manner. For example, the pusher 850 may be connected to thesled 482 directly or indirectly, such that the translation of the sled482 also causes translation of the pusher 850. As another example, thepusher 850 may be connected directly or indirectly to the second cable490, such that the second cable 490 pulls the pusher 850 distally. Asthe pusher 850 translates distally within the channel 246, the distalend of the pusher 850 contacts the projection 208 and urges theprojection 208 distally. The member 848 connected to the projection 208moves at substantially the same rate as the pusher 850. The projection208 is held substantially in the active position by this motion of themember 848 and by contact with the distal end of the translating pusher850. As the projection 208 translates distally, the edge 209 of theprojection moves through the tissue of the wall of the target vessel 580in a direction substantially parallel to the longitudinal centerline ofthe anvil arm 14, incising the tissue of the wall of the target vesselto create an arteriotomy. Because the projection 208 is translated bythe pusher 850, which is located in the anvil arm 14 that is in turnlocated within the target vessel 580, the arteriotomy is performed fromwithin the target vessel 580.

The length of that arteriotomy is related to the distance across whichthe projection 208 is translated. Thus, the pusher 850 translatesdistally across a distance substantially equal to the length of thearteriotomy, urging the edge 209 of the projection 208 through tissueacross that distance. Referring also to FIG. 117, when the arteriotomyis complete, the projection 208 has reached a final location distal toits starting point, and is moved no further in the distal direction. Themotion of the member 848 is controlled such that the final location ofthe projection 208 is substantially predictable. This control may beaccomplished in any appropriate manner with any appropriate structure ormechanism. As one example, the spring 852, member 848 and/or pusher 850contact the stop 856 in the course of proximal motion, and such contactsubstantially halts the forward motion of the projection 208. When theprojection 208 is in the active position, it is substantially sharp onat least a portion of its distal edge, which is the edge 209, andsubstantially blunt along its proximal edge. The projection 208 remainsin the final location in the active position until the anvil arm 14 iswithdrawn from the anvil entry hole 584. Referring also to FIG. 118, asthe anvil arm 14 is withdrawn from the anvil entry hole 584, the bluntproximal edge of the projection 208 encounters target vessel tissueadjacent to the anvil entry hole 584. Because that proximal edge of theprojection 208 is blunt, that contact causes the projection 208 torotate substantially about the axis of the aperture 849, into which themember 848 extends. This rotation causes the projection 208 to reenterthe channel 246 in the anvil arm 14 and come to rest in a withdrawalposition. In the withdrawal position, the projection 208 substantiallydoes not extend out of the anvil arm 14 in any direction, allowing for aminimal cross-section of material to be removed from the lumen of thetarget vessel 580 through the anvil entry hole 584.

Alternately, the projection 208 is oriented in the opposite direction,and the pusher 850 is configured to pull the projection 208 proximallyrather than push it distally. In such a configuration, when theprojection 208 is in the active position, the edge 209 is orientedproximally. The projection 208 is configured to be placed in awithdrawal position in a manner other than by contact with the wall ofthe target vessel 580, as contact between the edge 209 of the projectionand the wall of the target vessel 580 during withdrawal of the anvil arm14 may cause the anvil entry hole 584 to be enlarged.

The cutter 200 of FIGS. 119-122 is configured and operates similarly tothe cutter 200 of FIGS. 115-118. Referring to FIG. 119, the projection208 is initially in the stowed position, and is substantially restrainedfrom translation in that stowed position. The pusher 850 may berestrained substantially as described above, or in a different manner.The projection 208 includes a lobe 858 that is initially positioned atleast partially in a slot 860 in the bottom surface 266 of the channel246. The lobe 858 is located closer to the aperture 849 than is the end866 of the projection 208. The slot 860 may be defined in or completelythrough the bottom surface 266 of the channel 246.

Referring also to FIG. 120, the pusher 850 is advanced distallysubstantially as described above. The end 866 of the projection 208initially faces at least partially proximally, and is initially againstor in proximity to the distal end of the pusher 850. The motion of thepusher 850 exerts a force in the distal direction against the projection208, and contact between the pusher 850 and the projection 208 causesthe end 866 of the projection 208 opposite from the aperture 849 to moveupward. The angle or curvature of the distal end of the pusher 850allows the end 866 of the projection 208 to slide onto that distal endof the pusher 850, moving upward as it does so. The lobe 858 of theprojection 208 is initially in the slot 860, and contact between thelobe 858 and the distal edge of the slot 860 substantially prevents theprojection 208 from moving distally as the end 866 moves upward. Thatis, as the projection 208 rotates upward, at least part of the lobe 858remains in the slot 860 during that rotation until the projection 208reaches the active position. As the projection 208 moves upward, itmoves above the contact surface 206 of the anvil arm 14. The edge 209 ofthe projection 208 is oriented substantially upward, and extendssubstantially to the end 866 of the projection 208, which is the part ofthe projection 208 that encounters the tissue of the target vessel 580.That edge 209 incises the wall of the target vessel 580, causing theprojection 208 to cut through the target vessel wall 580. The cutter 200is now in the active position, with the projection 208 extending throughthe wall of the target vessel 580 and the edge 209 of the projection 208oriented in the direction in which the projection 208 is to be moved,which as shown is the distal direction.

As the projection 208 pivots about the axis of the aperture 849, thelobe 858 of the projection 208 moves upward and out of the slot 860,freeing the projection 208 for translation. Referring also to FIG. 121,the pusher 850 is then urged distally in any suitable manner. Forexample, the pusher 850 may be connected to the sled 482 directly orindirectly, such that the pusher 850 and the sled 482 translatetogether. As another example, the pusher 850 may be connected directlyor indirectly to the second cable 490, such that the second cable 490pulls the pusher 850 distally. As the pusher 850 translates distallywithin the channel 246, the distal end of the pusher 850 contacts theprojection 208 and urges the projection 208 distally. As anotherexample, referring also to FIG. 154, the pusher 850 may be connected tothe cutter pull 1096.

A clip 862 is connected to the projection 208, such as through theaperture 849. The clip 862 is configured to be held by and to slidealong tracks 864 in the interior surfaces 202 of the channel 246 in theanvil arm 14. In this way, the clip 862 is coupled to the anvil arm 14.The projection 208 is held in the active position substantially bycontact with the distal end of the pusher 850, and is stabilized as itmoves by contact between the clip 862 and the tracks 864. As theprojection 208 translates distally, the edge 209 of the projection movesthrough the tissue of the wall of the target vessel 580 in a directionsubstantially parallel to the longitudinal centerline of the anvil arm14, and incises the tissue of the wall of the target vessel to create anarteriotomy. Because the projection 208 is moved by the pusher 850,which is located in the anvil arm 14 that is in turn located within thetarget vessel 580, the arteriotomy is performed from within the targetvessel 580.

The length of the arteriotomy is related to the distance across whichthe projection 208 is translated. Thus, the pusher 850 translatesdistally across a distance substantially equal to the length of thearteriotomy, urging the edge 209 of the projection 208 through tissueacross that distance. Referring to FIG. 121, when the arteriotomy iscomplete, the projection 208 has reached a final location distal to itsstarting point, and is moved no further in the distal direction. Whenthe projection 208 is in the active position, it is substantially sharpon at least a portion of its distal edge, which is the edge 209, andsubstantially blunt along its proximal edge. The projection 208 remainsin that final location, in the active position, until the anvil arm 14is withdrawn from the anvil entry hole 584. Referring also to FIG. 122,as the anvil arm 14 is withdrawn from the anvil entry hole 584, theblunt proximal edge of the projection 208 encounters target vesseltissue adjacent to the anvil entry hole 584. Because that proximal edgeof the projection 208 is blunt, that contact causes the projection 208to rotate about the axis of the aperture 849, through which the clip 862extends. This rotation causes the projection 208 to reenter the channel246 in the anvil arm 14 and come to rest in the withdrawal position. Inthe withdrawal position, the projection 208 substantially does notextend out of the anvil arm 14 in any direction, allowing for a minimalcross-section of material to be removed from the lumen of the targetvessel 580 through the anvil entry hole 584.

Alternately, the projection 208 is oriented in the opposite direction,and the pusher 850 is configured to move the projection 208 proximallyrather than push it distally. In such a configuration, when theprojection 208 is in the active position, the edge 209 is orientedproximally. The projection 208 is configured to be placed in awithdrawal position in a manner other than contact with the wall of thetarget vessel 580, as contact between the edge 209 of the projection andthe wall of the target vessel 580 during withdrawal of the anvil arm 14may cause the anvil entry hole 584 to be enlarged.

Where the cutter 200 of FIGS. 125-128 is used, the cutter 200 initiallyis in the stowed position, in which it is substantially restrained fromtranslation. At least part of the lobe 858 is positioned at leastpartially within the receiving space 876. The first cam surface 878 islocated proximal to the lobe 858, and the structure of the centerpiece868 is located distal to the lobe 858, holding the lobe 858 is placewithin the receiving space 876 and thereby holding the projection 208 inthe stowed position. The projection 208 is substantially completelywithin the channel 246 in the anvil arm 14.

Referring also to FIG. 126, the member 848 is moved proximally. The lobe858 does not simply translate proximally due to the presence of thefirst cam surface 878. The aperture 849 in the projection 208 is locatedbelow the first cam surface 878. As a result, proximal motion of themember 848 creates a moment, causing the lobe 858 to rotate out of thereceiving space 876. The notch 859 in the projection 208 is shaped andsized to allow such rotation around the first cam surface 878. Contactbetween the first cam surface 878 and the lobe 858, as well as the shapeof the first cam surface 878 and the lobe 858 and the moment applied tothe projection 208, cause the projection 208 to rotate about theaperture 849 as the member 848 translates the aperture 849 proximally.As the lobe 858 rotates out of the receiving space 876, the free end 866at the other end of the projection 208 moves upward through the freespace 874 in the centerpiece 868 and above the contact surface 206 ofthe anvil arm 14 into the wall of the target vessel 580. As the end 866of the projection 208 moves upward, an edge 209 of the projection 208incises the wall of the target vessel 580, causing the projection 208 tocut through the target vessel wall 580. The cutter 200 is now in theactive position, with the projection 208 extending through the wall ofthe target vessel 580 and an edge 209 of the projection 208 oriented inthe direction in which the projection 208 is to be moved, which as shownis the proximal direction.

Referring also to FIG. 143, the member 848 continues to move proximally.This motion may be accomplished in any suitable manner. For example, themember 848 may be connected to the sled 482 directly or indirectly, suchthat the member 848 and the sled 482 translate proximally together. Asthe member 848 moves proximally within the channel 246, it causes theprojection 208 to move proximally as well. Optionally, a groove 964 isdefined in the bottom surface 266 of the channel 246. The groove 964 isslightly wider than the lobe 858 of the projection 208. As theprojection 208 rotates to the active position, as described above, atleast part of the lobe 858 enters the groove 964. Where the groove 964is provided, contact between the lobe 858 of the projection 208 and thegroove 964 as the projection 208 is moved proximally keeps theprojection 208 in the desired orientation and keeps the projection 208from moving out of contact with the wall of the target vessel 580. Thatis, the groove 964 provides lateral stability for the lobe 858,substantially preventing the lobe 858 from moving laterally duringproximal motion of the projection 208. The free space 874 within thecenterpiece 868 in the channel 246 of the anvil arm 14 may have a widthselected such that it stabilizes the projection 208 as it translates.That is, the free space 874 may be slightly wider than the thickness ofthe projection 208, thereby limiting the distance that the projection208 can move laterally as it translates.

The length of the arteriotomy is related to the distance across whichthe projection 208 is translated. This distance is controlled by thetranslation of the member 848 as well as the length of the free space874 in the centerpiece 868. Referring to FIG. 127, when the arteriotomyis complete, the projection 208 has reached a final location proximal toits starting point due to its contact with the proximal edge of the freespace 874 in the centerpiece 868. The member 848 continues to moveproximally. The projection 208 cannot translate further proximally dueto contact with the proximal edge of the free space 874, but can rotateabout the axis of the aperture 849. The second cam surface 880 is spacedapart from the bottom surface 266 of the channel 246 in the anvil arm14. The aperture 849 in the projection 208 is located below the secondcam surface 880. As a result, proximal motion of the member 848 createsa moment, causing the projection 208 to rotate about the axis of theaperture 849 as the member 848 moves proximally, and causing the freeend 866 of the projection 208 to rotate into the channel 246 in theanvil arm 14. At least a portion of the lobe 858 rotates into a secondreceiving space 882. The second receiving space 882 is formed into thecenterpiece 868 or a different structure or mechanism associated withthe anvil arm 14. As the lobe 858 rotates, at least a portion of thelobe 858 is free to rotate into or through the slot 860. The slot 860provides clearance for the motion of the lobe 858. Referring also toFIG. 128, motion of the projection 208 is then complete, with theprojection 208 in the withdrawal position. In the withdrawal position,the edges 209 of the projection 208 are within the channel 246 in theanvil arm 14, such that they do not incise tissue during removal of theanvil arm 14 through the anvil entry hole 584. However, at least part ofthe lobe 858 may extend through the slot 860 in the withdrawal position.If so, the lobe 858 is blunt such that motion of the lobe 858 againsttissue does not substantially disturb it.

The cutter 200 and the sled 482 may be configured to move proximallyrather than distally, regardless of the particular configuration of thecutter 200 or the sled 482. If so, the actuation of the cutter 200 andthe sled 482 proceeds substantially as described above, but in thereverse direction.

Where the cutter slide 1092 is used, a cutter pull 1096 may extenddistally from the cutter slide 1092 to the cutter 200 or projection 208,as described above. The cutter slide 1092 may be utilized whether thecutter 200 is actuated to move proximally or distally. Where the cutterslide 1092 moves proximally, the cutter pull 1096 may be rigid, such asa wire, or flexible, such as a cable. Where the cutter slide 1092 movesdistally, the cutter pull 1096 is advantageously substantially rigid inorder to push the cutter 200 and/or the projection 208 distally. Afterthe engagement member 216 and the receiver 218 engage one another, andthe second cable 490 causes the receiver 218 to move, the engagementmember 216 moves as well. This motion of the engagement member 216 inturn causes the cutter slide 1092 to move, which in turn moves thecutter pull 1096. Motion of the cutter pull 1096 moves the cutter 200and/or projection 208, substantially as described above. In this way,the cutter 200 and/or projection 208 can be moved without the firstcable 480 and the second cable 490 being directly connected to them.

Referring also to FIG. 95, regardless of the particular configuration ofcutter 200 or projection 208 utilized, the shield 290 may be used toprotect the tissue of the graft vessel 404 from the projection 208. Theprojection 208 of the cutter 200 may move upward out of the channel 246at a longitudinal position under the raised element 293 or the firstramp element 294. The raised element 293 of the shield 290 holds thetissue of the graft vessel 404 away from the path of motion of theprojection 208 to minimize or eliminate contact between the projection208 and the graft vessel 404. Where the shield 290 includes an aperture296, the aperture 296 is substantially aligned with the motion of theprojection 208. As the projection 208 begins to move upward above thecontact surface 206 of the anvil arm 14, its upper tip may enter theaperture 296. The shield 290 is shaped, and has a particular thickness,such that the upper tip of the projection 208 does not movesubstantially upward out of the aperture 296 to a position above theupper surface of the shield 290. In this way, the shield 290 protectsthe tissue of the graft vessel 404 from the projection 208. Alternately,the shield 290 does not include an aperture 296 therein. If so, theshield 290 is shaped, and extends far enough above the contact surface206 of the anvil arm 14, such that the projection 208 substantially doesnot contact the shield 290 as it emerges from the channel 246 in theanvil arm 14 or at other locations during its travel.

As the sled 482 continues to advance distally, the distal end 474 ofeach ramp element 476 actuates each connector deployer 452 in turn,causing the connector deployers 452 to sequentially deploy thecorresponding staples 446 as described above. Additionally, the veinknives 432 continue to move distally as the sled 482 advances distally,lengthening the incision in the root 405 of each flap 408. Further,referring also to FIG. 47, the cutter 200 continues to advance distallyas the receiver 218 continues to urge the engagement feature 216distally. The cutter 200 incises the wall of the target vessel at agiven longitudinal position at substantially the same time as each veinknife 432 incises the corresponding flap 408 at the that longitudinalposition. Alternately, the timing of the cutting action of the cutter200 and the vein knives 432 is different, such that the cutter 200incises the wall of the target vessel at a given longitudinal positioneither before or after each vein knife 432 incises the correspondingflap 408 at that longitudinal position.

The lower surface of the keel 264 contacts the bottom surface 266 of thechannel 246 during this translation. The contact between the keel 264and the bottom surface 266 of the channel 246 counteracts the downwardbias of the distal end of the cutter 200. In this way, the projection208 is maintained above the contact surface 206 of the anvil arm 14. Asthe cutter 200 continues to translate distally, the projection 208 movesthrough the tissue of the wall of the target vessel in a directionsubstantially parallel to the longitudinal centerline of the anvil arm14, and incises the tissue of the wall of the target vessel to create anarteriotomy. Because the projection 208 is connected to and translatedby the cutter 200, which is within the target vessel, the arteriotomy isperformed from within the target vessel. The tip of the projection 208may maintain substantially the same height relative to the contactsurface 206 of the anvil arm 14 during translation of the cutter 200, ormay change its height relative to the contact surface 206 of the anvilarm, as long as the projection 208 continues to incise completelythrough the wall of the target vessel.

Where the cutter of FIG. 43B is used, the lower surface of the secondkeel 265 and the lower surface of the first keel 264 both contact thebottom surface 266 of the channel 246. Alternately, the lower surface ofthe first keel 264 extends downward enough that the lower surface of thesecond keel 265 does not contact the bottom surface 266 of the channel246.

Referring also to FIG. 48, a second lower opening 268 is defined throughthe lower surface 256 of the anvil arm 14. The second lower opening 268is distal to and substantially aligned with the first lower opening 254.The cutter 200 continues to advance distally as the receiver 218continues to impel the engagement feature 216 distally. As a result ofthis translation, the keel 264 encounters the proximal end of the secondlower opening 268. Because the distal end of the cutter 200 is biaseddownward, the keel 264 moves downward at least partially into the secondlower opening 268. The downward motion of the keel 264 causes the distalend of the cutter 200 and the projection 208 to move downward. The keel264 and/or the proximal end of the second lower opening 268 may beconstructed to provide a smooth, gradual downward motion of the keel264, such as by providing a gradual slope on the keel 264 and/or theproximal end of the second lower opening 268. Alternately, the keel 264and/or the proximal end of the second lower opening 268 may beconstructed to allow or cause the keel 264 to move downward abruptlyupon encountering the proximal end of the second lower opening 268.Alternately, where the cutter 200 of FIG. 43B is used, the first keel264 moves as least partially into the third lower opening 269, and thesecond keel 264 moves at least partially into the second lower opening268. The downward motion of the distal end of the cutter 200 causes theprojection 208 to retract into or completely through the upper opening248, such that the projection 208 no longer encounters the tissue of thewall of the target vessel. The projection 208 may be urged downwardcompletely into the channel 246, depending on the depth of the channel246 and the height of the projection 208. As the projection 208 movesrelative to the anvil arm 14 and incises the wall of the target vessel580, the upper tip of the projection 208 travels along a path that maybe affected by several characteristics of the cutter 200 and the anvilarm 14, such as the size and shape of the keel 264 and the spacingbetween the lower openings 254, 268 in the anvil arm 14. Where theshield 290 is utilized, that path is related to the configuration of theshield 290. If the shield 290 includes an aperture 296 therein, theshield 290 is shaped, and has a particular thickness at eachlongitudinal point, such that the upper tip of the projection 208 doesnot move substantially upward out of the aperture 296 to a positionabove the upper surface of the shield 290. In this way, the shield 290protects the tissue of the graft vessel 404 from the projection 208during motion of the projection 208. The tip element 297 of the shield290 protects the graft vessel 404 in the event that the projection 208contacts the shield 290 near the end of the stroke of the cutter 200. Ifthe shield 290 does not include an aperture 296 therein, the shield 290is shaped, and extends far enough above the contact surface 206 of theanvil arm 14, such that the projection 208 substantially does notcontact the shield 290 as it moves. As a result, the shield 290 withoutthe aperture 296 therein may extend further above the contact surface206 of the anvil arm 14 than would the shield 290 with the aperture 296therein.

Alternately, the upper tip of the projection 208 may remain within theupper opening 248. The cutter 200 may stop its distal translation atsubstantially the same time that the projection 208 retracts completelyinto the upper opening 248, or may continue to translate distally withinthe channel 246 before coming to a stop. Alternately, the second loweropening 268 is not provided, and only the first lower opening 254extends through the lower surface 156 of the anvil arm 14 into thechannel 246. In such a configuration, the cutter 200 is retracted in theproximal direction after the arteriotomy is formed, until the keel 264moves downward into the first lower opening 254 and the projection 208consequently retracts completely into the upper opening 248.

Operation of Anastomosis Tool—Completion of Anastomosis

The sled 482 continues to move distally, such that the distal end 474 ofthe ramp element 446 actuates the most distal connector deployer 452 anddeploys the corresponding staple 446. Referring also to FIG. 76, theconnection between the end of the graft vessel 404 and the target vessel580 is then complete. The sled 482 continues to translate, such thateach vein knife 432 then moves completely through the corresponding flap408. A portion of each flap 408 continues to be held between each graftclip 412 and corresponding flap receiving surface 406. Thus, when theroot 405 of each flap 408 has been completely incised through by thecorresponding vein knife 432, the staple holder 38 no longer holds thegraft vessel 404, and is freed from the anastomosis site.

Referring to FIG. 72, the rocker 508 completes its travel when thedistal end 520 of the distal arm 516 contacts one or more of the ribs556 in the handle 302. This contact prevents further downward motion ofthe distal arm 518, and thereby causes the rocker 508 to cease itsmotion. Alternately, at least a portion of the distal arm 516 and/or theproximal arm 514 contact a stop or other structure in the handle 302which obstructs further motion of the rocker 508. Alternately, themotion of the rocker 508 is stopped in a different way, such as by abraking or clutch mechanism. Thus, the corresponding travel of thesecond cable 490 and the connected sled 482 cease as well. After therocker 508 has completed its travel, the upper portion 532 of thecontact feature 528 of the proximal slider 522 contacts the proximal end516 of the proximal arm 514. The spring 546 biases the proximal slider522 distally. Thus, the upper portion 532 of the contact feature 528 ispressed against the proximal end 516 of the proximal arm 514, holdingthe proximal arm 514 and the rocker 508 in place and substantiallypreventing rotation of the rocker 508 in a direction opposite to itsprevious motion. Alternately, the proximal slider 522 does not contactthe rocker 508 after the travel of the rocker 508 is complete. Atsubstantially the same time as the motion of the rocker 508 stops, thelower guide 552 of the distal slider 534 contacts a stop 553 defined inor connected to the handle 302. The stop 553 may be integrated with atleast one of the ribs 556. The stop 553 is positioned to interfere withfurther proximal motion of the distal slider 534, such that contactbetween the lower guide 552 and the stop 553 causes the distal slider534 to cease moving proximally. Alternately, the stop 553 is not used,and the distal slider 534 is allowed to continue to move proximallyafter deployment of the staples 446. Referring also to FIG. 77, this istime t=4, at which the distal slider 534 has moved proximally from itsposition at time t=3, and the proximal slider has moved slightlydistally from its position at time t=3.

As described above, the distal slider 534 may include a verificationstub 560 that extends substantially upward from the upper end of thedistal slider 534 through a slot 562 in the handle 302. Initially, whenthe distal slider 534 is in its most distal position, the verificationstub 560 is also in its most distal position. As the distal slider 534translates proximally during actuation of the anastomosis tool 300, theverification stub 560 also translates proximally. Thus, after theanastomosis tool 300 has been actuated and the distal slider 534 hasmoved to its most proximal position, the verification stub 560 has movedto its most proximal position as well. By visually inspecting theposition of the verification stub 560, the user can confirm whether theanastomosis tool 300 has been completely actuated. In addition, thedistal end 474 of at least one ramp element 446 may be visible afteractuation of the anastomosis tool 300 if the distal end 442 of thepassage 440 is open, providing another visual indication that theanastomosis tool 300 has been completely actuated. The distal end of thefirst lower opening 254 and the proximal end of the second lower opening268 control the motion of the projection 208 and thereby control thepenetration of the wall of the target vessel. That is, the distancebetween the distal end of the first lower opening 254 and the proximalend of the second lower opening 268 determines the length of thearteriotomy.

Alternately, where the snap arm 606 is used instead of the cam lock tohold a corresponding graft clip 412 in the closed position, the distalend 474 of the corresponding ramp element 446 extends out of the distalend 442 of the passage 440 to disengage the catch 608 of the snap arm606. That is, the lobe 610 of the snap arm 606 is positioned relative tothe distal end 442 of the passage 440 such that the distal end 474 ofthe corresponding ramp element 446 encounters the lobe 610 near the endof the travel of the ramp element, pushing the lobe 610 out ofengagement of the arm 402 and thus disengaging the catch 608 from thearm 402. The corresponding graft clip 412 is thereby free to move out ofthe closed position, freeing the flap 408 held by that graft clip 412.In such an embodiment, the vein knives 432 may be omitted, because theflaps 408 are freed in their entirety. Further, the spikes 410 areomitted, such that the flaps 408 are not held in place on the flapreceiving surface 406 after the snap arm 606 is disengaged from the arm402. Alternately, at least one vein knife 432 may be omitted, and atleast one graft clip 412 is simply moved from the closed position to theopen position after the anastomosis is complete, thereby freeing eachassociated flap 408. Such motion may be performed by hand, or by theanastomosis tool 300 itself by any suitable mechanism. Force exerted onthe graft clip or clips 412 to move them from the closed position to theopen position is sufficient to unsnap the graft clip or clips 412 fromthe arms 402, overcome the cam lock between the graft clip or clips 412and the arm, or otherwise overcome the force or forces holding the graftclip or clips 412 in the closed position.

After performing the arteriotomy, the cutter 200 is in adistally-extended position. The cutter 200 remains in that position asthe anvil arm 14 is removed from the target vessel 580, where the tissuebridge 582 separates the anastomosis site from the anvil entry hole 584in the wall of the target vessel 580. Thus, the projection 208 does notextend out of the upper opening 248 during removal of the anvil arm 14from the target vessel 580. Alternately, after performing thearteriotomy, the cutter 200 may be moved proximally within the channel246 in the anvil arm 14 before removing the anvil arm 14 from the targetvessel 580.

The tissue effector 400 is then returned to the open position from theclosed position, to allow the anvil arm 14 to be withdrawn from thetarget vessel 580. Where the graft affixer 910 is used, the graftaffixer 910 moves out of the wall of the target vessel 580 as the tissueeffector 400 moves to the open position. Preferably, the diameter of thegraft affixer 910 is small enough that substantially no leakage occursfrom the target vessel 580 after its removal from the wall thereof.Where the graft affixer 910 is a heel clip 910, the closed heel clip 910separates from the staple holder 38 and remains in tissue, as describedabove. After the trigger 308 has been depressed to deploy one or moreconnectors 464, the distal arm 518 of the rocker 508 has deflected atleast a portion of the holder 594. As a result, the deflected holder 594exerts an opposing bias against the distal arm 518 of the rocker 508.When the user releases the trigger 308, the biased holder 594 then actsagainst the distal arm 518, pushing it upward and causing the rocker 508to rotate about the rocker axle 510. As a result, the proximal arm 514of the rocker 508 moves downward toward its original position. Thus, theproximal end 516 of the proximal arm 514 moves downward against theupper portion 532 of the contact feature 528 of the proximal slider 522,and continues to move downward past the intersection between the twoportions 530, 532 of the contact feature 528. As the proximal end 516 ofthe proximal arm 514 moves past that intersection to contact the lowerportion 530 of the contact feature 528, the proximal slider 522 is freedto move distally a small amount due to the bias of the spring 546. Thisproximal motion relaxes the tension on the first cable 480. As a result,the biasing element 475 pushes the staple holder 38 away from the anvil10, returning the tissue effector 400 to the open position. The tissueeffector 400 thus no longer clamps the wall of the target vessel 580,and the anvil arm 14 can be removed from the lumen of the target vessel580. The spacing between the staple holder 38 and the anvil 10 in theopen position is selected to ensure adequate clearance for separation ofthe tissue effector 400 from the target vessel 580. For example, thestaple holder 38 is moved far enough from the anvil 10 such that thespikes 410 are fully removed from the flaps 408 before the anvil arm 14is removed from the target vessel 580. Alternately, the tissue effector400 is returned to the open position in another manner. When theprojection 208 is retracted out of the tissue of the wall of the targetvessel, the distal end of the arteriotomy is defined, and thearteriotomy is complete. Thus, referring also to FIG. 73, theanastomosis between the graft vessel 404 and the target vessel 580 iscomplete as well. The spacing between the connectors 464 is such thatthere is substantially no leakage at the anastomosis. For example, thespacing between the connectors 464 may be comparable to the spacingbetween sutures in a conventional hand-sewn anastomosis. When the anvilarm 14 is withdrawn from the anvil entry hole 584 in the target vessel580, the shield 290 (if utilized) slides out of the heel 587 of theanastomosis. The shield 290 may do so whether it is connected to theanvil 10 or to the staple holder 38. The shield 290 is sized and shapedsuch that it can exit through the heel 587 without substantiallydisturbing the anastomosis. For example, the shield 290 may be thin andnarrow, and flexibly connected to the anvil arm 14, such that it canslip out of the heel 587 substantially without affecting the tissue ofthe graft vessel 404 or the target vessel 580 and substantially withoutresulting in leakage at the heel 587. Further, the shield 290 may becomposed of a flexible material such as polyethylene that facilitatesthe flexing and removal of the shield 290 from the anastomosis.

Alternately, referring also to FIGS. 144-145, the shield 290 may beremoved through the toe 585 of the anastomosis. As the tissue effector400 moves back to the open position, the distal end of the staple holder38 moves away from the anastomosis, such as by rotating away from it. Asthe distal end of the staple holder 38 moves, contact between the shield290 and the graft vessel 404 causes the shield 290 to rotate about thehinge 966. Further, as the distal end of the staple holder 38 moves awayfrom the anastomosis, it moves the hinge 966 away from the anastomosis.The combination of the motion of the shield 290 about the hinge 966 andthe motion of the hinge 966 itself away from the anastomosis causes theshield 290 to slide smoothly out of the toe 585 of the anastomosis. Theshield 290 is shaped to facilitate its smooth withdrawal in this manner,such that the shape of the shield 290 works in conjunction with the pathof motion of the shield 290 as it is withdrawn. Alternately, where thehinge 966 is not used, the shield 290 is flexible enough to allow it toflex adequately to be removed from the toe 585 of the anastomosis. Thisflexibility also minimizes or prevents any disturbance to the toe 585 ofthe anastomosis during withdrawal of the shield 290 from it.

Where the most proximal connector bay 448 and/or the most distalconnector bay 448 in an arm 402 is offset toward the longitudinalcenterline of the anvil arm 14 relative to one or more other connectorbays 448, the corresponding connectors 464 at the heel 587 and/or toe585 of the anastomosis are closer to one another than are connectors 464on opposite sides of the anastomosis that were deployed from the otherconnector bays 448. By placing the connectors 464 at the heel 587 and/ortoe 585 of the anastomosis closer to one another, sealing of theanastomosis may be enhanced. Similarly, where the longitudinalcenterline of each connector bay 448 forms a large angle relative to thelocal horizontal, such an angle may hold the lateral sides of theanastomosis closer together and thus may enhance sealing. Such an anglemay be used in addition to offsetting at least one connector bay 448 toprovide enhanced sealing.

Referring also to FIG. 135, where the graft affixer 910 is used and thegraft vessel 404 has a single flap 408 at one end, the resultinganastomosis may include a tissue overhang 926 at the toe 585, extendingbeyond the connectors 464 deployed into the graft vessel 404 and thetarget vessel 580 to create the anastomosis. The tissue overhang 926 isat least partially in contact with the outer surface of the targetvessel 580, and may contribute to sealing or minimizing any minorleakage that may be present at the toe 585 of the anastomosis.Optionally, the overhang 926 may be trimmed from the graft vessel 404,at the discretion of the surgeon. The overhang 926 is orientedsubstantially longitudinally relative to the target vessel 580. Forexample, the overhang 926 extends away from the toe 585 of theanastomosis in a direction substantially parallel to the longitudinaldimension of the target vessel 580. Alternately, the overhang 926 isoriented differently relative to the target vessel 580.

Alternately, the graft affixer 910 is configured substantially asdescribed above, but is positioned on the staple holder 38 such that itaffixes a location on the graft vessel 404 corresponding to the toe ofthe anastomosis to the staple holder 38. Thus, the graft affixer 910 ispositioned on the staple holder 38 in a location distal to the locationit would occupy if it were to affix the heel of the graft vessel 404 tothe staple holder 38. The anastomosis then may be performed in a reversedirection as compared to the anastomosis where the graft affixer 910engages the heel of the graft vessel 404. That is, the anvil arm 14 isoriented in the opposite direction relative to the target vessel 580,and the anvil entry hole 584 may be located downstream from thearteriotomy, rather than upstream from it, depending on the direction offlow of fluid through the target vessel 580. As a result, the tissueoverhang 926 covers the anvil entry hole 584. Thus, the tissue overhang926 contributes to the elimination or reduction of minor leakage fromthe anvil entry hole 584 after removal of the anvil arm 14 therefrom.Optionally, a composition such as an adhesive is used to hold the tissueoverhang 926 onto the target vessel 580 and enhance its ability toeliminate or reduce leakage. A sealer 780 as described below may beutilized to substantially seal the anvil entry hole 584, as well.

Optionally, the staple holder 38 includes a deployment indicator 968.Referring to FIGS. 146-147, the deployment indicator 968 may include awindow 970 in the upper surface of the staple holder 38. The window 970may be simply an opening in the upper surface of the staple holder 38.Alternately, clear plastic or other suitable transparent or translucentmaterial may be placed over, under or in the opening. The deploymentindicator 968 may also include an indicia 972 associated with the sled482. The indicia 972 may be a hole or opening in the sled 482, a symbolon the sled 482, a region of color on the sled 482, or any othersuitable indicia. The indicia 972 is placed at a location on the sled482 that is positioned under the window 970 after the sled 482 hascompleted its motion and deployed the connectors 464. In this way, theindicia 972 is visible to the operator after the sled 482 has completedits motion. Visibility of the indicia 972 through the window 970confirms that the connectors 464 have all been deployed.

Operation of Anastomosis Tool—Fluid-Driven Actuator

An anastomosis tool 300 that utilizes a fluid-driven actuator 1000 maybe operated in a similar manner as that described above. For brevity,only the significant differences between the operation of an anastomosistool 300 that utilizes a fluid-driven actuator 1000 and the operation ofan anastomosis tool 300 that utilizes a different source of energy forits operation are described below.

Initially, a source of pressurized gas is made available to thefluid-driven actuator 1000. As one example, referring to FIGS. 152-153,a gas cylinder 1046 is held within the handle 302 of the anastomosistool 300. In order to make the gas in the gas cylinder 1046 available,and begin the operation of the anastomosis tool 300, a user turns theknob 1048. The spindle 1049 advances distally as the knob 1048 isturned. As the spindle 1049 advances, it pushes the gas cylinder 1046distally. As the spindle 1049 continues to advance, it pushes the neckend 1047 of the gas cylinder 1046 against the spike 1064. Continuingadvancement of the spindle 1049 exerts greater force against the gascylinder 1046, and thereby between the neck end 1047 of the gas cylinder1046 and the spike 1064. The increase in force causes the spike 1064 topuncture and enter the neck end 1047 of the gas cylinder 1046. Theaperture 1066 in the spike 1064 also enters the gas cylinder 1046. Inthis way, gas flows from the gas cylinder 1046 into the aperture 1066,and thereby into the gas inlet 1036 of the fluid-driven actuator 1000.The force exerted on the gas cylinder 1046 by the spindle 1049 holds thegas cylinder 1046 substantially fixed onto the spike 1064, andsubstantially prevents leakage between the gas cylinder 1046 and thespike 1064.

Where the knob 1048 includes an indicator 1080, such as a substantiallyplanar tab extending from the proximal end of the knob 1048, theposition of that indicator 1080 in a particular position providespositive confirmation that the gas cylinder 1046 has been punctured. Forexample, where the indicator is a substantially planar tab, itsorientation relative to the handle 302 and/or a marker on the handle 302confirms that the knob 1048 is in the activation position and that thegas cylinder 1046 has been punctured by the spike 1064. Further, thesecond notch 1062 in the spindle 1049 may engage the stop 1054 after theknob 1048 has been moved to the activation position. Contact between thesecond notch 1062 and the stop 1054 stops the motion of the spindle 1049when the knob 1048 has been moved to the activation position. In thisway, the knob 1048 can be rotated far enough to release gas from the gascylinder 1046, but not so far as to damage the gas cylinder 1046 and/orthe handle 302 of the anastomosis tool 300. Alternately, any othersuitable structure, mechanism or method may be used to make pressurizedgas available to the fluid-driven actuator 1000. For example, where anexternal gas source is utilized, that external gas source may beconnected directly or indirectly to the gas inlet 1036 in order to makepressurized gas available.

The fluid-driven actuator 1000 is configured to transition among atleast two states. Referring to FIG. 149, the fluid-driven actuator 1000is in a first state, which also may be referred to as the neutral stateor the initial state. In this first state, the sealing elements 1006along the control member 1002, in conjunction with the gas inlet orifice1038 in the first chamber 1004, define a first gas path associated withthe first state of the fluid-driven actuator 1000. When gas is receivedinto the first chamber 1004 through the gas inlet orifice 1038, that gastravels along the first gas path.

In the initial state of the fluid-driven actuator 1000, sealing elementsA, B associated with the control member 1002 are positioned on oppositesides of the gas inlet orifice 1038. The sealing element A is positionedproximal to the gas inlet orifice 1038, and the sealing element B ispositioned distal to the gas inlet orifice 1038. No other orifices arelocated in the first chamber 1004 between the sealing elements A, B whenthe fluid-driven actuator 1000 is in the initial state. Thus, thepressurized gas from the gas inlet orifice 1038 is trapped between thesealing elements A, B. This is the first gas path, which is lightlyshaded in FIG. 149. The diameter of the first chamber 1004 issubstantially constant between the sealing elements A, B, and each ofthe sealing elements A, B extends into contact with the wall of thefirst chamber 1004. Thus, the pressurized gas trapped between thesealing elements A, B exerts substantially the same amount of force oneach of those sealing elements A, B. However, that force is exertedproximally on sealing element A and distally on sealing element B, suchthat the two forces cancel out one another, and the control member 1002does not substantially move in response to the entry of pressurized gasto the space defined between the sealing elements A, B. Thus, in theneutral state, the pressurized gas entering the first chamber 1004 viathe gas inlet orifice 1038 does not move the control member 1002substantially, and thus the fluid-driven actuator 1000 does not movesubstantially as a whole.

The operator inserts the anvil arm 14 of the tissue effector 400 intothe lumen of the target vessel 580 at a desired location, substantiallyas described above. Next, referring also to FIG. 152, the operatordepresses the trigger 308. The trigger 308 rotates about the projections1034 relative to the handle 302. Alternately, the trigger 308 movesdifferently relative to the handle 302. As the trigger 308 rotates aboutthe projections 1034 or otherwise moves relative to the handle 302, thetransverse member 1032 of the trigger 308 moves proximally. Thetransverse member 1032 engages the slot 1017 of the control member 1002,such that the proximal motion of the transverse member 1032 moves thecontrol member 1002 proximally. Referring also to FIG. 148, the proximalmotion of the transverse member 1032 is halted by contact between thetab or tabs 1014 extending from the control member 1002 and the surface1016 of the body 1018 in which the first chamber 1004 is defined.Alternately, proximal motion of the transverse member 1032 is halted ina different manner.

When the tab or tabs 1014 of the control member 1002 stop the proximalmotion of the control member 1002, the fluid-driven actuator 1000 is inthe second position, which also may be referred to as the clampingposition. Referring to FIG. 150, in the clamping position, the sealingelement B of the control member 1002 is proximal to the gas inletorifice 1038. Also in the clamping position, a sealing element C of thecontrol member 1002 is distal to both the sealing element B and to thegas inlet orifice 1036. Thus, the sealing elements B, C seal thepressurized gas entering the first chamber 1004 between them. The ribs1008 adjacent to the sealing elements B, C do not extend all the way tothe wall of the first chamber 1004, at least along the entirecircumference of each rib 1008. Thus, compressed gas entering the firstchamber 1004 from the gas inlet orifice 1038 moves distally past the rib1008 distal to and in proximity to the sealing element B.

The gas path within the fluid-driven actuator 1000 in the clampingposition is lightly shaded in FIG. 150. Further, for clarity, arrowheadsindicate the direction of gas flow through the passages of thefluid-driven actuator 1000 along that gas path. As compressed gas movesfrom the gas inlet orifice 1038 distally past the rib 1008 distal to andin proximity to the sealing element B, it is prevented from movingfurther distally in the first chamber 1004 than the sealing element C.Passages P1 and P2 extend from the first chamber 1004 to the secondchamber 1012. An orifice O1 exists in the wall of the first chamber 1004at the intersection between the passage P1 and the first chamber 1004.An orifice O2 exists in the wall of the first chamber 1004 at theintersection between the passage P2 and the first chamber 1004. When thecontrol member 1002 is in the clamping position, the orifices O1 and O2are between the sealing elements B and C. Thus, in the clampingposition, compressed gas flows out of the volume of the first chamber1004 between the sealing elements B, C and into the orifices O1, O2,then through the passages P1, P2 into the second chamber 1012.

An orifice O3 exists in the wall of the second chamber 1012 at theintersection between the passage P1 and the second chamber 1010. Anorifice O4 exists in the wall of the second chamber 1012 at theintersection between the passage P2 and the second chamber 1012. Sealingelements D, E are positioned relative to the clamping member 1010 suchthat, in the clamping position, the orifices O3 and O4 are locatedbetween the sealing elements D, E. The sealing element D is locatedproximal to the sealing element E. The second chamber 1012 may beconfigured to have a first cross-sectional area at a more-distallocation, and a second, larger cross-sectional area at a more-proximallocation. As a result, the sealing element D, which is positioned withinthe portion of the second chamber 1012 having a larger cross-sectionalarea, has a larger surface area than the sealing element E, which ispositioned within the portion of the second chamber 1012 having asmaller cross-sectional area. Consequently, the pressurized gas enteringthe second chamber 1012 through the orifices O3, O4 exerts more force onthe larger sealing element D than on the smaller sealing element E,because the scalar value of force is equal to pressure multiplied by thearea acted on by that pressure. Thus, more force is exerted on thesealing element D than on the sealing element E. The greater forceexerted on the sealing element D is substantially in the proximaldirection, and the lesser force exerted on the sealing element E issubstantially in the distal direction, such that the net force on theclamping member 1010 is exerted in the proximal direction. As a result,the clamping member 1010 moves proximally. Alternately, the forcedifferential on the clamping member 1010 that causes the clamping member1010 to move proximally is generated in a different manner. Proximalmotion of the clamping member 1010 continues until the proximal end ofthe clamping member 1010 encounters the proximal end of the secondchamber 1012. Alternately, the proximal motion of the clamping member1010 is limited or controlled in a different or additional manner.

The first cable 480 is connected to the clamping member 1010 asdescribed above, such as by the hook 1020 at the distal end of theclamping member 1010. Thus, as the clamping member 1010 movesproximally, the clamping member 1010 pulls the first cable 480proximally. This motion of the first cable 480 moves the tissue effector400 to the closed position, as described above. As an example, referringto the exemplary embodiment of FIG. 154, as the first cable 480 movesproximally, it pulls the staple holder 38 downward toward the anvil arm14, which remains substantially stationary. Motion of the first cable480 is translated into downward force on the staple holder 38 by theaxle 1082.

If the operator decides to move the tissue effector 400 relative to thetarget vessel 580, he or she may simply release the trigger 308. Upondoing so, the control member 1002 moves back to the position it occupiesin the neutral position. As a result, the first cable 480 relaxes, andthe tissue effector 400 moves back to the open position. The controlmember 1002 may be biased to the position it occupies in the neutralposition, such as by a spring 1003 or other biasing member. Such biasingexerts a force on the trigger 308, tending to move it back to itsoriginal position. For example, distal motion of the control member 1002results in distal motion of the slot 1017 therein, which in turn movesthe transverse member 1032 of the trigger 308 distally, returning thetrigger 308 to its initial position. A passage P3 may be connected tothe second chamber 1012 and to the first chamber 1004. An orifice O5exists at the interface between the passage P3 and the second chamber1012, and an orifice O6 exists at the interface between the passage P3and the first chamber 1004. The orifice O5 is proximal to the orificeO3, and the orifice O6 is proximal to the orifice O1. Referring also toFIG. 149, when the control member 1002 moves back to the position itoccupies in the neutral position, the most-proximal sealing element 1006on the control member 1002 is distal to the orifice O5, allowingpressurized gas in the second chamber 1012 to vent through the passageP3 into the proximal end of the first chamber 1004, and then through theoutlet orifice 1042 and then the gas outlet 1040. A return spring (notshown) is positioned in the proximal portion of the second chamber 1012,and exerts a force in the distal direction on the clamping member 1010.As an example, the return spring is a compression spring that coilsaround the proximal end of the clamping member 1010, with one end thatpresses against the most proximal rib 1008 of the clamping member 1010,and an opposite end that presses against the proximal end of the secondchamber 1012. By exerting a distal force on the clamping member 1010,the return spring returns the clamping member 1010 to its originalposition after the pressurized gas has been vented. Similarly, a returnspring (not shown) is positioned in the proximal portion of the thirdchamber 1028, and exerts a force in the distal direction on the firingmember 1026. As an example, the return spring is a compression springthat coils around the proximal end of the firing member 1026, with oneend that presses against the most proximal rib 1008 of the firing member1026, and an opposite end that presses against the proximal end of thethird chamber 1028. By exerting a distal force on the firing member1026, the return spring returns the firing member 1026 to its originalposition after the pressurized gas has been vented. Upon moving thetissue effector 400 to a new position, the user may actuate the trigger308 again, thereby moving the tissue effector 400 back to the closedposition. Thus, the fluid-driven actuator 1000 may be configured to movethe tissue effector 400 to and from the open and closed positions, untilthe operator is satisfied with the position of the tissue effector 400relative to the target vessel 580.

After the operator has moved the tissue effector 400 to the closedposition in a suitable location of the target vessel 580, referring alsoto FIG. 152, the operator further depresses the trigger 308. The trigger308 rotates about the projections 1034 relative to the handle 302.Alternately, the trigger 308 moves differently relative to the handle302. As the trigger 308 rotates about the projections 1034 or otherwisemoves relative to the handle 302, the transverse member 1032 of thetrigger 308 moves proximally. The transverse member 1032 engages theslot 1017 of the control member 1002, such that the proximal motion ofthe transverse member 1032 moves the control member 1002 proximally.Referring also to FIG. 148, the application of greater force to thetrigger 308 causes the ramp surfaces 1015 of the tabs 1014 to be pressedinward toward the longitudinal axis of the control member 1002 as aresult of contact between the ramp surfaces 1015 and the end of thefirst chamber 1004. After the tabs 1014 have moved inward a sufficientamount, the tabs 1014 are able to move into, and the control member 1002is able to move along, the first chamber 1004 until the end of thecontrol member 1002 opposite the tabs 1014 contacts the correspondingend of the first chamber 1004. This contact stops the motion of thecontrol member 1002 at a defined third position. Alternately, thecontrol member 1002 is stopped at a defined third position in anothermanner. In this way, the trigger 308 provides two-stage actuation. Thatis, a small amount of force applied to the trigger 308 is sufficient tomove the fluid-driven actuator 1000 from the initial position to theclamping position, but a larger amount of force is required to move thefluid-driven actuator 1000 from the clamping position to the firingposition. In this way, the operator can actuate the trigger 308 andclose the tissue effector 400 without inadvertently deploying theconnectors 464 at the same time. Alternately, the fluid-driven actuator1000 only has two states, in which case actuation of the trigger 308with a single amount of force both closes the tissue effector 400 anddeploys the connectors 464. Alternately, the tabs 1014 are not movableinto the first chamber 1004.

Referring also to FIG. 151, when the control member 1002 contacts theend of the first chamber 1004 and such contact stops the proximal motionof the control member 1002, the fluid-driven actuator 1000 is in thethird position, which also may be referred to as the firing position.The gas path within the fluid-driven actuator 1000 in the clampingposition is lightly shaded in FIG. 151. Further, for clarity, arrowheadsindicate the direction of gas flow through the passages of thefluid-driven actuator 1000 along that gas path. In the firing position,the sealing element B of the control member 1002 is proximal to the gasinlet orifice 1038 and the orifice O1, and the sealing element C of thecontrol member 1002 is distal to the gas inlet orifice 1038 and theorifice O1, and proximal to the orifice O2. Thus, in the firingposition, compressed gas flows into the volume of the first chamber 1004between the sealing elements B, C, then through the orifice O1 and thepassage P1 into the second chamber 1012 through the orifice O3.

The pressurized gas enters the second chamber 1012 through the orificeO3, between the sealing elements D, E. As described above with regard tothe clamping position, the pressure of the gas between the sealingelements D, E creates a net proximal force on the clamping member 1010,moving it to a proximal position and thereby actuating the first cable480 to move the tissue effector 400 to the closed position. In thefiring position, the sealing element A of the control member 1002 islocated between the gas outlet orifice 1042 and the orifice O6 thatexists at the interface between the passage P3 and the first chamber1004, and the sealing element B of the control member 1002 is locatedbetween the orifice O6 and the gas inlet orifice 1038. In this way,pressurized gas that escapes the second chamber 1012 through the orificeO5 and the passage P3 enters the portion of the first chamber 1004between the sealing elements A, B, and is trapped therebetween whileexerting substantially no net force on the control member 1002.

In the firing position, the sealing element C of the control member 1002is located proximal to the orifice O2 and distal to the orifice O1 inthe first chamber 1004, and the sealing element E of the clamping member1010 is located distal to the orifice O4 in the second chamber 1012.Thus, pressurized gas flows out of the second chamber 1012 through theorifice O4 and the passage P2, and into the first chamber 1004 throughthe orifice O2. The control member 1002 includes a sealing element Glocated distal to the sealing element C. When the control member 1002 isin the firing position, the sealing element G is located distal to anorifice O7 that exists at the interface between a passage P4 and thefirst chamber 1004. The passage P4 connects the first chamber 1002 andthe second chamber 1012. An orifice O8 exists at the interface betweenthe passage P4 and the second chamber 1012. Pressurized gas receivedinto the first chamber 1004 through the orifice O2 thus travels out ofthe orifice O7, through the passage P4, and into the second chamber 1012through the orifice O8.

In the firing position, the sealing element E of the clamping member1010 is positioned proximal to the orifice O8, and the sealing element Fof the clamping member 1010 is positioned distal to the orifice O9. Thepressurized gas entering the second chamber 1012 through the orifice O8exerts substantially the same amount of force on each of the sealingelements E, F, but in opposite directions, such that the pressurized gasbetween the sealing elements E, F exerts substantially no net force onthe clamping member 1010. An orifice O9 exists in the second chamber1012 at the interface between a passage P5 and the second chamber 1012.In the firing position, the sealing element F of the clamping member1010 is located distal to the orifice O9. The passage P5 connects thesecond chamber 1012 to the third chamber 1028. An orifice O10 exists atthe interface between the passage P5 and the third chamber 1028. Thus,in the firing position, pressurized gas travels from the second chamber1012 between the sealing elements E, F out of the orifice O9, throughthe passage P5, and into the third chamber 1028 through the orifice O10.

Advantageously, the placement of the orifices and of the sealingelements 1006 ensures that the clamping member 1010 is positioned tohold the tissue effector 400 in the closed position before pressurizedgas is allowed into the third chamber 1028. That is, gas cannot flowinto the third chamber 1028 until the clamping member 1010 has beenmoved to a position that actuates the tissue effector 400 to the closedposition. The firing member 1026 includes a sealing element I that ispositioned distal to the orifice O10 and a sealing element H that ispositioned proximal to the sealing element I. The third chamber 1028 maybe configured to have a first cross-sectional area at a more-distallocation, and a second, larger cross-sectional area at a more-proximallocation. As a result, the sealing element H, which is positioned withinthe portion of the third chamber 1028 having a larger cross-sectionalarea, has a larger surface area than the sealing element I, which ispositioned within the portion of the third chamber 1028 having a smallercross-sectional area. Consequently, the pressurized gas entering thethird chamber 1028 through the orifice O10 exerts more force on thelarger sealing element H than on the smaller sealing element I, becausethe scalar value of force is equal to pressure multiplied by the areaacted on by that pressure. Thus, more force is exerted on the sealingelement H than on the sealing element I. The greater force exerted onthe sealing element H is substantially in the proximal direction, andthe lesser force exerted on the sealing element I is substantially inthe distal direction, such that the net force on the firing member 1026is exerted in the proximal direction. As a result, the firing member1026 moves proximally. Alternately, the force differential on the firingmember 1026 that causes the firing member 1026 to move proximally isgenerated in a different manner.

The second cable 490 is connected to the firing member 1026 as describedabove, such as by the hook 1020 at the distal end of the firing member1026. Thus, as the firing member 1026 moves proximally, the firingmember 1026 pulls the second cable 490 proximally. This motion of thesecond cable 490 actuates the sled 482 to deploy the connectors 464 andcreate an arteriotomy with the cutter 200 and/or projection 208, asdescribed in greater detail elsewhere in this document. Proximal motionof the firing member 1026 continues until the proximal end of the firingmember 1026 encounters the proximal end of the third chamber 1028.Alternately, the proximal motion of the firing member 1026 is limited orcontrolled in a different or additional manner.

An orifice O12 exists at the interface between a passage P6 and thethird chamber 1028. The orifice O12 is located proximal to the orificeO10. An orifice O13 exists at the interface between the passage P6 andthe first chamber 1004. The orifice O13 is located proximal to theorifice O6. In the firing position, pressurized gas travels through theorifice O12 in the third chamber 1028 into the passage P6 and out of theorifice O13. The sealing element A is positioned distal to the orificeO13, and a sealing element J connected to the control member 1002 ispositioned proximal to the orifice O13. The pressurized gas is thustrapped, and pressure is maintained within the fluid-driven actuator1000.

After the connectors 464 have been deployed, the trigger 308 isreleased. The fluid-driven actuator 1000 thus moves back from the firingposition to the clamping position and then to the neutral position. Whenthe fluid-driven actuator 1000 moves back to the clamping position, thesealing element J of the control member 1002 is positioned distal to theorifice O13, as shown in FIG. 150. Thus, pressurized gas is ventedthrough the passage P6 and the orifice O13 to the gas outlet orifice1042 and then out of the gas outlet 1040. As the fluid-driven actuator1000 returns to the neutral position, additional gas may be ventedthrough the passage P3 and the orifice O6 to the gas outlet orifice 1042and then out of the gas outlet 1040, as described above.

The topology of the fluid-driven actuator 1000 described above may beimplemented in any appropriate manner with regard to route, shape,configuration and other properties of the passages, orifices and otherelements thereof. Further, other topologies of the fluid-driven actuator1000 may be utilized in order to move the tissue effector 400 from theopen to the closed position and then to deploy a plurality of connectors464 to connect the graft vessel 404 to the target vessel 580. As aresult of the use of the fluid-driven actuator 1000, a user mayexperience little or no recoil during actuation of the anastomosis tool300.

Optionally, the pressure regulation assembly 1070 regulates the pressureof the gas released by the gas cylinder 1046. Initially, the pressureregulation assembly 1070 is positioned as shown in FIG. 163. Thepressure control member 1072 is biased to an initial position by thebiasing element 1074. For example, the proximal end of the pressurecontrol member 1072 may be biased into contact with the proximal end ofthe regulator space 1078 by the biasing element 1074. The sealingelements K, L are located proximal to the orifice O15 in the wall of theregulator space 1078, and the sealing element M is located distal to theorifice O15.

After the spike 1064 has punctured the neck end 1047 of the gas cylinder1046, gas enters the regulator space 1078. The regulator space 1078 maybe configured to have a first cross-sectional area at a more-distallocation, and a second, smaller cross-sectional area at a more-proximallocation. As a result, the sealing element M, which is positioned withinthe portion of the regulator space 1078 having a larger cross-sectionalarea, has a larger surface area than the sealing element L, which ispositioned within the portion of the regulator space 1078 having asmaller cross-sectional area. Consequently, the pressurized gas enteringthe regulator space 1078 through the orifice O15 exerts more force onthe larger sealing element M than on the smaller sealing element L. Thegreater force exerted on the sealing element M is substantially in thedistal direction, and the lesser force exerted on the sealing element Lis substantially in the proximal direction, such that the net force onthe pressure control member 1072 is exerted in the distal direction. Asa result, the pressure control member 1072 moves distally, against theforce exerted in the proximal direction by the biasing element 1074.Alternately, the force differential on the pressure control member 1072that causes the pressure control member 1072 to move distally isgenerated in a different manner.

Distal motion of the pressure control member 1072 continues until thesealing element L moves to a location at which that sealing element Lblocks the orifice O15, as shown in FIG. 164. Alternately, the proximalmotion of the pressure control member 1072 is limited or controlled in adifferent or additional manner. Pressurized gas that is located in theregulator space 1078 between the sealing elements L, M escapes theregulator space 1078 through the orifice O14 into the gas inlet 1036.Referring also to FIG. 165, the stop 1076 may provide a hard stop thatlimits distal travel of the pressure control member 1072. The stop 1076may be positioned such that it stops the pressure control member 1072 ata position in which the orifice O15 is located between the sealingelements K, L, blocking the influx of pressurized gas into the regulatorspace 1078. In such a position, the pressure control member still allowspressurized gas that is located in the regulator space 1078 between thesealing elements L, M to escape through the orifice O14.

As pressurized gas continues to escape through the orifice O14, thepressure in the regulator space 1078 between the sealing elements L, Mdecreases, because the blockage of the orifice O15 by the sealingelement L prevents additional gas from entering the regulator space1078. As a result of the pressure decrease, the force exerted distallyon the sealing element M decreases to a value less than the forceexerted proximally on the pressure control member 1072 by the biasingelement 1074. As a result, the pressure control member 1072 movesproximally, such as to the position shown in FIG. 164, so that thesealing element L no longer blocks the orifice O15. Pressurized gas canthen enter the regulator space 1078 through the orifice O15, repeatingthe actions described above. In this way, the pressure control member1072 oscillates, thereby controlling the pressure that is delivered tothe gas inlet 1036 through the orifice O14. The gas pressure passinginto the aperture may vary substantially sinusoidally or otherwisewithin an upper limit and a lower limit, as the pressure control member1072 moves back and forth. Alternately, the pressure of the gas releasedfrom the gas cylinder 1046 may be regulated by a different and/oradditional structure or mechanism, by a structure and/or mechanismoutside the anastomosis tool 300, or by a different method.

After the anastomosis is complete, the tissue effector 400 then may beremoved from the anastomosis site, and optionally the anvil entry hole584 may be sealed as described below. Referring also to FIG. 146, wherea deployment indicator is used, the deployment indicator 968 confirmsthat the sled 482 has completed its motion, and that the connectors 464have all been deployed. For example, where an indicia 972 is associatedwith the sled 482, motion of the sled 482 as a result of motion of thesecond cable 490 moves the indicia 972 under the window 970, such thatthe operator can view the indicia 972 and confirm that the sled 482 hascompleted its motion. However, any other suitable deployment indicator,and/or other information associated with completed motion of the sled482 and/or deployment of the connectors 464, may be utilized to confirmdeployment of the connectors 464.

Sealer

After the anastomosis is complete and the anvil arm 14 has been removedfrom the lumen of the target vessel 580, the anvil entry hole 584 thatremains in the wall of the target vessel 580 is small enough to preventsignificant bleeding therethrough. To that end, the anvil entry hole 584may be less than substantially 2 mm wide, and advantageously less than 1mm wide. Alternately, the anvil entry hole 584 is closed by handsuturing. Alternately, the anvil entry hole 584 is closed with abiocompatible glue, adhesive or the like. Alternately, the anvil entryhole 584 is closed with a clip, clamp, or other implantable device thatremains on the target vessel. Such a device may be positioned on theouter surface and/or inner surface of the target vessel, and may extendinto the anvil entry hole 584. A sealer for closing the anvil entry hole584 may be constructed from nitinol or other superelastic orpseudoelastic material, or from stainless steel or other material, wherethat device moves between a first configuration and a secondconfiguration during deployment, and where the second configurationholds the anvil entry hole 584 closed.

Referring to FIGS. 96-97, a sealer 780 includes at least one securingelement 782 and at least one plug element 784. The sealer 780 may bedetachably connected to the anvil arm 14 at its distal end or at adifferent location thereof, in such a way that the presence of thesealer 780 does not substantially interfere with the motion of thecutter 200. Alternately, the sealer 780 may be detachably connected tothe staple holder 38. Alternately, the sealer 780 is applied to theanvil entry hole 584 with a tool separate from the tissue effector 400.The securing element or elements 782 may be any structure and/ormechanism that can engage the tissue of the target vessel 580. As oneexample, at least one securing element 782 may be a hook 782. Each hook782 is oriented such that its free end 786 extends at least partially inthe proximal direction, and such that it is substantially blunt in thedistal direction. The free end 786 of at least one hook 782 may includea barb. Each hook 782 may be smoothly curved, angled, or shaped in anyother appropriate manner. Each hook 782 is connected to a plug element784, which may be proximal to the hook or hooks 782. Where multiplehooks 782 are used, they may be spaced substantially evenly and/orsymmetrically about a plug element 784, or may be spaced unevenly and/orasymmetrically about the central element 784. The plug element 784 maybe substantially cylindrical, substantially linear, convoluted,straight, curved, or shaped in any other appropriate manner. Similarly,the plug element 784 may be formed from any appropriate material orcombination of materials, such as polytetrafluoroethylene. As oneexample, the plug element 784 includes an assemblage of one or moreflexible elements tightly or loosely coiled or otherwise bunched ortangled into a fibrous mass. The flexible elements may be absorbent,expandable, coated with a coagulant, coated with an adhesive such asfibrin glue and/or have one or more other useful properties. Theflexible elements may be fibers, filaments or other structures. Theflexible elements may form the plug element 784, or may be a portion ofa complete plug element 784. As another example, the plug element 784includes a solid element, such as a shaft or cylinder, instead of or inaddition to one or more flexible elements. The solid element may becomposed of any biocompatible material, such as stainless steel ornitinol. One or more flexible elements such as described above may beconnected to the solid element. The plug element 784 is detachablyconnected to the anvil arm 14. Alternately, one or more securingelements 782 are detachably connected to the anvil arm 14 instead of orin addition to the plug element 784. Optionally, at least a portion ofthe sealer 780 is formed from a resorbable material.

In operation, the anvil arm 14 is inserted into the lumen of the targetvessel through the anvil entry hole 584 substantially as describedabove. The sealer 780 is connected to the anvil arm 14, such as at itsdistal end. Each hook 782 of the sealer 780 is curved such that its freeend 786 is oriented proximally, and the portion of the hook 782 that isoriented distally is substantially blunt. In this way, the sealer 780does not substantially engage the tissue of the target vessel 580, orsubstantially enlarge the anvil entry hole 584, as the anvil arm 14enters the anvil entry hole 584. The connectors 464 are deployed toperform anastomosis substantially as described above. After theanastomosis is complete, the anvil arm 14 is moved proximally. As thedistal end of the anvil arm 14 (which is in the lumen of the targetvessel 580) approaches the anvil entry hole 584, the free end 786 ofeach hook 782 encounters the inner surface of the target vessel 580. Asthe anvil arm 14 continues to move proximally and exit the anvil entryhole 584, the free end 786 of each hook 782 engages the tissue of thetarget vessel 580. This engagement between one or more hooks 782 and thewall of the target vessel 580 causes the sealer 780 to resist furtherproximal motion. This resistance, coupled with the continued proximalmotion of the anvil arm 14, causes the sealer 780 to detach from theanvil arm 14. The anvil arm 14 then exits the anvil entry hole 584 andmoves away from the anastomosis site. The sealer 780 is left behind andheld substantially in place by engagement between the hooks 782 and thetarget vessel 580. The plug element 784 of the sealer 780 thus extendsat least partially into the anvil entry hole 584. The presence of theplug element 784 at least partially within the anvil entry hole 584 actsto minimize or eliminate temporary leakage through the anvil entry hole584. Depending on the material utilized to form the plug element 784,the plug element 784 may expand within the anvil entry hole 584 tofacilitate sealing. For example, where the plug element 784 includes abundle of flexible elements such as fibers, those flexible elements mayexpand. Further, the plug element 784 may include an adhesive orcoagulant, and/or may deliver a therapeutic agent to the tissue inproximity to the anvil entry hole 584, that assists in sealing the anvilentry hole 584.

Referring to FIGS. 98-99, another example of a sealer 780 includes aplug element 784 that is a stopper 784. The stopper 784 is composed of abiocompatible material such as silicone. The cross-section of thestopper 784 is sized and shaped to substantially match the size andshape of the anvil entry hole 584. For example, where the anvil entryhole 584 is substantially circular, the stopper 784 is substantiallycylindrical, with a diameter substantially the same as the diameter ofthe anvil entry hole 584. The stopper 784 may be sized to be slightlylarger than the anvil entry hole 584, in order to fit within the anvilentry hole 584 snugly. The stopper 784 may be delivered to the anvilentry hole 584 in any appropriate manner. As one example, the stopper784 includes an aperture 792 therethrough, through which a line 794extends. The line 794 may be a strand of polytetrafluoroethylene, sutureor any other appropriate material. The line 794 may be connected to atleast one securing element 798, such as described above with regard toFIGS. 96-97, where that securing element 798 engages the target vessel580. The stopper 784 then is urged distally along the line 794 until thestopper 784 moves into the anvil entry hole 584 and/or into substantialcontact with the tissue of the target vessel 580 in proximity to theanvil entry hole 584. As described above with reference to FIGS. 96-97,at least part of the surface of the stopper 784 may be treated with acoagulant and/or other therapeutic substance. After the stopper 784 hasengaged the tissue of the target vessel 580, optionally at least part ofthe line 794 extending out of the stopper 784 may be cut off andremoved. Alternately, the line 794 is not secured to the target vessel580 and is removable therefrom. If so, the securing element or elements798 may be omitted, and the stopper 784 is held in place in the anvilentry hole 784 by contact with the tissue surrounding the anvil entryhole 784. In such an embodiment, the stopper 784 itself constitutes theentire sealer 780.

Referring to FIGS. 100-101, another example of a sealer 780 includes aplug element 784 that is a balloon 784. The balloon 784 is made of abiocompatible material such as silicone or latex. The balloon 784includes an open end (not shown), which may be positioned inside thelumen of the target vessel 580 or outside the lumen of the target vessel580. The open end of the balloon 784 may be secured to the inner surfaceof the target vessel 580 with at least one securing element 798 attachedthereto, such as described above with regard to FIGS. 96-97.Alternately, the balloon 784 may engage the target vessel 580differently. Referring to FIG. 102, the balloon 784 initially is in adeflated state, and at least part of the balloon 784 extends through theanvil entry hole 584. The open end of the balloon 784 is positioned inthe lumen of the target vessel 580, but is blocked or otherwise closedby the anvil arm 14 (not shown). The anvil arm 14 is then removed fromthe lumen of the target vessel 580 through the anvil entry hole 584.Blood is then free to flow into the open end of the balloon 784,expanding it to reduce or eliminate leakage through the anvil entry hole584. As described above with reference to FIGS. 96-97, at least part ofthe surface of the balloon 784 may be treated with a coagulant and/orother therapeutic substance. Alternately, the open end of the balloon784 is located outside the target vessel 580. The balloon 784 is filledwith fluid, and its open end closed, after the anvil arm 14 is removedfrom the target vessel 580. The securing element or elements 798 may beomitted, such that the balloon 784 is held in place in the anvil entryhole 784 by contact with the tissue surrounding the anvil entry hole784. In such an embodiment, the balloon 784 itself constitutes theentire sealer 780.

Referring to FIGS. 102-103, another example of a sealer 780 includes aplug element 784 that is an expandable structure. Such a sealer 780includes an expandable frame (not shown) covered at least in part byfabric 796, such as DACRON® brand polyester from DuPont Corporation. Thefabric 796 may be substantially impermeable to blood. The frame may becomposed at least in part of nickel-titanium alloy or other superelasticalloy. Alternately, the frame is composed at least in part of adifferent expandable substance, where that substance may be elasticallydeformable or plastically deformable. Alternately, a material other thanfabric 796 covers at least part of the frame, and/or the fabric 796 isomitted altogether. Such a sealer 780 may be detachably connected to theanvil arm 14 at any appropriate location. The plug element 784 may beconnected to at least one securing element 798, such as described abovewith regard to FIGS. 96-97. Alternately, the securing element orelements 798 may be omitted, such that the plug element 784 is held inplace in the anvil entry hole 784 by contact with the tissue surroundingthe anvil entry hole 784. In such an embodiment, the plug element 784itself constitutes the entire sealer 780. Initially, as shown in FIG.102, the plug element 784 is in an undeployed state. When the anvil arm14 is removed from the anvil entry hole 584, the plug element 784remains in place within or adjacent to the anvil entry hole 584. Theplug element 784 is configured to expand from the undeployed state to adeployed state after removal of the anvil arm 14, as shown in FIG. 103.The frame expands to a circumference at least substantially equal to thecircumference of the anvil entry hole 584, causing the fabric 796 toexpand and substantially seal the anvil entry hole 584.

Referring to FIG. 104, another example of a sealer 780 includes a plugelement 784 that is composed of super-absorbent material such aspolyacrylate. This plug element 784 may be shaped and sized in anyappropriate manner for placement at least partially within or inproximity to the anvil entry hole 584. For example, the plug element 784may be initially small compared to the size of the anvil entry hole 584,but then expand upon absorbing blood to minimize or prevent leakagethrough the anvil entry hole 584. The plug element 784 may be connectedto at least one securing element 798, such as described above withregard to FIGS. 96-97. Alternately, the securing element or elements 798may be omitted, such that the plug element 784 is held in place in theanvil entry hole 784 by contact with the tissue surrounding the anvilentry hole 784. In such an embodiment, the plug element 784 itselfconstitutes the entire sealer 780. The plug element 784 may beginexpanding when the anvil arm 14 enters the anvil entry hole 584. Thus,when the anvil arm 14 is removed from the anvil entry hole 584, itleaves a space between the plug element 784 and a segment of the anvilentry hole 584. However, due to the superabsorbency of the material fromwhich it is formed, the plug element 784 expands further to fill thatspace. Thus, the sealer minimizes or stops leakage through the anvilentry hole 584.

Referring to FIG. 105, another embodiment of a sealer 780 is shown. Atleast one sealer 780 is used, where each sealer 780 includes an securingelement 798 connected to a plug element 784. Advantageously, two sealers780 are used; however, a single sealer 780 or more than two sealers 780may be used if desired. Each securing element 798 is a strand, line,sheet, strip, or other configuration of material. Each securing element798 may be detachably connected to the anvil arm 14, such as byadhesive. Alternately, at least one securing element 798 is simply heldagainst or in proximity to the anvil arm 14 without being detachablyconnected to it. Each securing element 798 may be placed on a differentsurface of the anvil arm 14, such that each securing element 798 coversat least one staple bending feature 572 of the anvil arm 14 at least inpart. At least one plug element 784 includes an assemblage of one ormore flexible elements tightly or loosely coiled or otherwise bunched ortangled into a fibrous mass. The flexible elements may be absorbent,expandable, coated with a coagulant, coated with an adhesive such asfibrin glue and/or have one or more other useful properties. As oneexample, such flexible elements may be fabricated frompolytetrafluoroethylene. The flexible elements may be fibers, filamentsor other structures. Each plug element 784 is positioned at the proximalend of the corresponding securing element 798. Alternately, at least oneplug element 784 is positioned at a different location relative to thecorresponding securing element 798. Each plug element 784 andcorresponding securing element 798 may be composed of the same material,or of different materials. Further, each plug element 784 andcorresponding securing element 798 may be manufactured as a singleunitary structure, or may be made from two or more separate piecesconnected together. As one example, each plug element 784 andcorresponding securing element 798 are made of a single piece ofpolytetrafluoroethylene. Other biocompatible materials may be used ifdesired. Alternately, the plug element 784 of at least one sealer 780 ofFIG. 105 may be configured in any other suitable manner, such asdescribed above with regard to FIGS. 98-104.

Referring also to FIG. 34, each plug element 784 may be positioned at ornear the proximal end of the anvil arm 14, such as in proximity to thetissue stop 220. The plug elements 784 may extend away from the anvilarm 14, such that they do not substantially enter the lumen of thetarget vessel 580 through the anvil entry hole 584. Alternately, atleast a portion of at least one plug element 784 enters the lumen of thetarget vessel 580. Optionally, the tissue stop 220 may be omitted, if atleast one of the plug elements 784 extends away from the anvil arm 14such that contact between those plug elements 784 and the outer surfaceof the target vessel 580 stops the motion of the anvil arm 14 duringinsertion in the same manner as the tissue stop 220.

The anvil arm 14 is inserted into the target vessel 580 as describedabove. When the connectors 464 are deployed, at least one connector 464engages a securing element 798 of a sealer 780 as that connector 464moves toward its corresponding staple bending feature 572. At least oneconnector 464 may penetrate the securing element 798, grab the securingelement 798, or otherwise engage the securing element 798 as it deploys.In this way, at least one connector 464 engages a securing element 798as well as the target vessel 580, thereby securing the sealer 780 to thetarget vessel 580. Advantageously, two or more connectors 464 may engageeach securing element 798. The anvil arm 14 is then withdrawn throughthe anvil entry hole 584 as described above; the sealer 780, beingrestrained against proximal motion by its engagement with the targetvessel 580, detaches from the anvil arm 14. At least a portion of eachsecuring element 798 remains in the lumen of the target vessel 580, heldby one or more connectors 464 to the target vessel 580. That is, one ormore connectors 464 secure a corresponding securing element 798 totissue, such that each plug element 784 remains in position adjacent toand/or at least partially in the anvil entry hole 584. Thus, eachsecuring element 798 holds the corresponding plug element 784 in placein proximity to the anvil entry hole 584. The plug element or elements784 minimize or eliminate temporary leakage through the anvil entry hole584, and/or promote coagulation at the anvil entry hole 584. At leastone plug element 784 may be treated with a coagulant and/or othertherapeutic substance, as described above with regard to FIGS. 96-97.

Sealer—Clip

Referring to FIG. 106, the sealer 780 may be at least one clip 800. Eachclip 800 may be detachably connected to the anvil arm 14 in any suitablemanner. For example, the clip 800 may be pressure-fit to the anvil 10,or may be connected to the anvil 10 by a frangible link or otherstructure or mechanism. The clip or clips 800 are connected to the anvilarm 14 distal to the tissue stop 220. Alternately, the clip 800 may belocated adjacent to or in contact with the tissue stop 220. If desired,at least one clip 800 may replace the tissue stop 220. Alternately, atleast one clip 800 is detachably connected to the staple holder 38 inany suitable manner. Each clip 800 may be shaped in any manner thatfacilitates sealing of the anvil entry hole 584. The clip 800 may beformed from a single wire or other structure, or may be fabricated fromtwo or more different parts assembled together to form the clip 800.

Referring also to FIG. 129, the clip 800 may include at least onepenetrating element 884. The penetrating element or elements 884 aresized to penetrate only partially into the target vessel 580.Alternately, at least one penetrating element may be configured topenetrate completely through the wall of the target vessel. Alternately,the penetrating element or elements 884 do not penetrate the targetvessel 580 at all, and instead grip the outer surface of the targetvessel 580. The clip 800 is substantially bilaterally symmetrical, butmay be formed in an asymmetrical manner if desired. The distal end ofthe clip 800 is open, and two penetrating elements 884 are positioned atthat distal end, spaced apart from and facing one another. Alternately,the penetrating element or elements 884 are positioned differently. Thepenetrating element or elements 884 are oriented at least partially inthe proximal direction to facilitate engaging tissue, as described ingreater detail below. Extending proximally from each penetrating element884 is a clip arm 886. Alternately, at least one clip arm 886 includestwo or more penetrating elements 884. The clip arms 886 are spaced apartfrom one another. Moving proximally, the clip arms 886 are bent, curvedor otherwise shaped such that they are spaced apart from one another bya lesser distance. This region of the clip arms 886 may be described asthe anvil engagement region 888. Moving proximally, each clip arm 86 isconnected to a spring 890. Each spring 890 is configured to bias thecorresponding clip arm 886 inward toward the longitudinal centerline ofthe clip 800. The springs 890 are connected to one another by a crossbar892.

Advantageously, all of the components of the clip 800 are part of aunitary structure, such as a wire that is formed into the configurationof the clip 800. However, the clip 800 may be composed of two or moreseparate components that are connected together. The clip 800 may beformed from nickel-titanium alloy, stainless steel or any otherappropriate material. The clip 800 may be superelastic, elastic,plastically deformable, or it may have other properties and/or acombination of these properties under stress or in deformation.

Referring also to FIG. 106, in an exemplary embodiment, the clip 800 maybe connected to the anvil 10 by a pressure fit. That is, the anvilengagement regions 888 of the clip 800 are biased toward one another bythe springs 890, and a portion of the anvil 10 is located between theanvil engagement regions 888 that are biased together. As one example,the anvil 10 may include an indentation 894 on either side thereof thatis configured to be held by the anvil engagement regions 888 of the clip800. Each indentation 894 is open at its distal end and closed at itsproximal end. That is, each anvil engagement region 888 is allowed totranslate out of the distal end of the corresponding indentation 894,but is not allowed to translate substantially proximally out of theindentation 894. Further, a ledge 896 may extend substantiallylongitudinally along the bottom of at least one indentation, where thatledge 896 prevents the clip 800 from moving downward out of theindentation. The clip 800 is positioned on the anvil 10 such that thepenetrating elements 884 are positioned longitudinally at approximatelythe same location as the tissue stop 220, and on laterally opposed sidesof the tissue stop 220. Advantageously, the penetrating elements 884 maybe located a short distance distal from the tissue stop 220.

The anastomosis is performed as described above, and the anvil arm 14 isthen moved proximally to begin its exit from the lumen of the targetvessel 580 through the anvil entry hole 584. As the anvil arm 14 movesproximally, the penetrating element or elements 884 engage the tissue ofthe target vessel 580. Alternately, at least one penetrating element 884engages the tissue of the target vessel 580 prior to motion of the anvilarm 14. For example, the anvil arm 14 may be substantially stationary,and the clip 800 may detach from the anvil arm 14 as the clip arms 886move toward one another. Because the penetrating element or elements 884are oriented distally, this engagement causes the clip 800 to begin toresist proximal motion. Due to the relative locations of the penetratingelements 884 and the tissue stop 220, the penetrating elements 884engage the target vessel 580 substantially on opposite sides of theanvil entry hole 584. As the anvil 10 continues to move proximally, suchresistance generates a force on the clip 800. When that force exceedsthe frictional force between the anvil engagement regions 888 of theclip 800 and the anvil 10, the anvil 10 begins to move proximallyrelative to the clip 800. The indentation 894 is open at its distal end,allowing the clip 800 to slide out distally. As the anvil 10 continuesto move proximally, the anvil engagement regions 888 move out of theindentation 894 altogether. At that time, the springs 890 urge the anvilengagement regions 888 and the clip arms 886 toward one another. Thismotion of the clip arms 886 toward one another on opposite sides of theanvil entry hole 584 substantially seals the anvil entry hole 584.Alternately, the clip 800 or other sealer 780 may be placed onto thetarget vessel 580 to substantially seal the anvil entry hole 584 inanother manner. For example, the clip 800 or other sealer 780 may bedetachably connected to the staple holder 38 rather than the anvil 10.As another example, a separate tool may be utilized to place one or moreclips 800 and/or other sealers 780 onto the target vessel 580 tosubstantially seal the anvil entry hole 584.

Referring to FIGS. 107-108, another exemplary clip 800 is open-ended,with a bridge 802 at its proximal end connecting two spaced-apartoutriggers 804. The bridge 802 extends above and between the outriggers804, accommodating the anvil arm 14. That is, the bridge 802 extendsalong at least part of the perimeter of the anvil entry hole 584, andallows the anvil arm 14 to slide out of the lumen of the target vessel580 relative to it. At least one outrigger 804 may include an engagementregion 806 configured to be engaged by a corresponding connector 464when the connectors 464 are deployed. The engagement region 806 may beshaped or configured in any appropriate manner. As one example, theengagement region 806 is a curved or convoluted portion of the outrigger804, extending above a remainder of the outrigger 804. However, theengagement region 806 may be shaped differently if desired.

Referring also to FIGS. 109-110, another exemplary clip 800 has a closedperimeter. A bridge 802 is located at the proximal end of the clip 800,and may be configured to accommodate the anvil arm 14 as describedabove. Moving distally, at least one engagement region 806 is defined inor attached to the clip 800. Each engagement region 806 may beconfigured substantially as described above. A second bridge 807connects the outriggers 804 at or near their distal ends, closing theperimeter of the clip 800. The second bridge 807 is configured similarlyto the bridge 802 to accommodate the anvil arm 14 in the same manner asthe bridge 802. Initially, the clip 800 may be in a first position. Theclip 800 may be held in that first position by contact with the anvilarm 14. The bridge 802 may rotate or move downward from that firstposition, as shown in FIG. 110, to a second position to substantiallyseal the anvil entry hole 584. Alternately, the bridge 800 and/or otherportion of the clip 800 may be configured to seal the anvil entry hole584 in a different manner.

The clip 800 may be composed of superelastic material such asnickel-titanium alloy, or of elastic material. If so, the clip 800 isconfigured such that it self-deforms to compress the tissue in proximityto the anvil entry hole 584 when it is detached from the anvil arm 14 orother portion of the tissue effector 400. The clip 800 may be configuredto self-deform from a first stable configuration while it is attached tothe anvil 10 or other portion of the tissue effector 400 to a secondstable configuration after it has been detached. However, the clip 800need not transition between stable configurations in order to seal theanvil entry hole 584. Alternately, the clip 800 may be composed ofplastically deformable material such as stainless steel. If so, the clip800 is deformed in some manner to seal the anvil entry hole 584, such asby motion of one or more connectors 464, one or more structures ormechanisms connected to or formed into the anvil 10, and/or one or morestructures or mechanisms connected to a different portion of the tissueeffector 400.

Referring to FIGS. 64 and 106-110, the clip 800 is positioned on orrelative to the anvil arm 14 or other portion of the tissue effector 400such that at least one connector 464 is deployed from the staple holder38 to engage a corresponding engagement region 806 of the clip 800. Asone example, the clip 800 is positioned on or relative to the anvil arm14 such that when the tissue effector 400 is in the closed position, atleast one engagement region 806 of the clip 800 is aligned with acorresponding connector bay 448 defined in an arm 402 of the stapleholder 38. That is, at least one engagement region 806 is positioned sothat at least a portion thereof is located between a correspondingconnector bay 448 and the anvil arm 14, such that deployment of aconnector 464 from the connector bay 448 causes that connector 464 toengage the engagement region 806 of the clip 800. Advantageously, theclip 800 is positioned such that at least one engagement region 806 isaligned with the most-proximal connector bay 448 in an arm 402 of thestaple holder 38. However, the clip 800 may be aligned with one or moredifferent connector bays 448. The clip 800 advantageously includes atleast two engagement regions 806, where at least one engagement region806 is aligned with a connector bay 448 in one arm 402 of the stapleholder 38 and at least one other engagement region 806 is aligned with aconnector bay 446 in the other arm 402 of the staple holder 38, suchthat the clip 800 can be engaged by at least one connector 464 on eachside of the anastomosis.

Where a clip 800 is used to seal the anvil entry hole 584, theanastomosis is performed substantially as described above. Referring toFIGS. 64 and 106-110, as the anvil arm 14 is inserted into the lumen ofthe target vessel 580 through the anvil entry hole 584, the tissue stop220 contacts the target vessel 580 to stop distal motion of the anvil10. Alternately, the clip 800 may be utilized instead of the tissue stop220 to contact the surface of the target vessel and cause distal motionof the anvil arm 14 to stop. If so, the tissue stop 220 may be omittedfrom the anvil 10. Alternately, the clip 800 is positioned on the anvil10 proximal to the tissue stop 220, and the tissue stop 220 is utilizedas described above.

The sealer 780 may be any other appropriate structure or mechanism, andneed not be connected to the anvil 10. For example, the sealer 780 maybe an adhesive patch placed onto the target vessel 580 over the anvilentry hole 584. As another example, the anastomosis tool 300 may includea mechanism configured to spray or otherwise deliver a substance to theanvil entry hole 584 to substantially seal it. Such a substance may bean adhesive such as cyanoacrylate or fibrin, a coagulant, or any othersuitable substance. Such substance may be held in a reservoir or othercontainer in the anastomosis tool 300 until it is delivered to the anvilentry hole 584. As another example, energy such as thermal energy orradio frequency (RF) energy may be applied to the anvil entry hole 584to seal it substantially. For example, RF energy may be applied to theanvil arm 14 as it is removed from the anvil entry hole 584,substantially sealing it. As another example, RF energy may be appliedto the anvil entry hole 584 by one or more structures or mechanismsother than the anvil arm 14 that are part of or connected to theanastomosis tool 300, wherein those energy-applying structures ormechanisms are placed on the target vessel 580 on or in proximity to theanvil entry hole 584. As another example, the sealer 780 may be aone-piece device having spaced-apart arms, or a multi-piece devicehaving independent, separate arms, at least one of which is magnetizedor has a magnet included therein. As the anvil arm 14 is withdrawn, thearms catch on the wall of and become connected to the target vessel 580in proximity to the anvil entry hole 584. Magnetic force draws the armstogether to substantially seal the anvil entry hole 584. Any combinationof features described above may be utilized in a particular sealer 780,as appropriate.

The connectors 464 are deployed as described above. At least oneconnector 464 engages an engagement region 806 of the clip 800 as it isdeployed. As one example, where at least one connector 464 is a staple,the engagement region 806 is a wire, strut, thin region, or otherstructure that is narrower than the staple and at an angle relative tothe body of the staple. The staple is deployed such that the bodycontacts the engagement region 806 and the legs straddle the engagementregion 806, such that when the legs are deformed by contact with theanvil arm 14 the staple securely holds the clip 800 relative to thetarget vessel 580. Advantageously, at least one staple on each side ofthe anastomosis engages an engagement region 806 of the clip 800, andsuch staples are in the most proximal location or locations of theanastomosis. Alternately, additional and/or different staples engage theclip 800.

The anastomosis is completed as described above, and the anvil arm 14 isthen moved proximally to begin its exit from the lumen of the targetvessel 580 through the anvil entry hole 584. The clip 800 is secured inplace relative to the anvil entry hole 584 by its engagement with atleast one connector 464 that has connected the tissue of the graftvessel 404 to the tissue of the target vessel 580. Thus, as the anvilarm 14 moves proximally, at least one connector 464 holds the clip 800against that motion. As a result, a force is exerted on the clip 800that causes the clip 800 to detach from the anvil 10. The clip 800 isdetachably connected to the anvil 10 in such a manner that the forcerequired to detach the clip 800 from the anvil 10 is low enough that thetissue effector 40 does not damage tissue as the anvil arm 14 is movedout of the lumen of the target vessel 580, but large enough such thatthe clip 800 does not become disconnected from the anvil 10 before theanastomosis is complete and the anvil arm 14 is moved out of the lumenof the target vessel 580. The clip 800 is thereby left in place on thetarget vessel 580. The clip 580 self-deforms or is deformed to from thefirst position to the second position, such that it substantially sealsthe anvil entry hole 584. At least a portion of the clip 800 may extendacross the perimeter of the anastomosis, if desired.

Sealer—Separate Applier

Referring to FIGS. 136-138, at least one sealer 780 may be held anddeployed by an applier 930 separate from the anastomosis tool 300. Thesealer 780 utilized with the applier may be a clip 800, or any othersuitable sealer 780 such as described above. The applier 930 may besized and configured to be held in a surgeon's hand, by a surgicalinstrument such as forceps or needle holders, or any other suitabletool. An exemplary applier 930 includes two arms 932 connected at ornear their proximal ends and biased apart from one another at theirdistal ends. The applier 930 may be fabricated as a unitary mechanism,or may be assembled from two or more separate pieces.

Each arm 932 may include a latch 934 extending toward the opposite arm932. The latches 934 may be positioned in proximity to the distal endsof the arms 932, or at different positions relative to each arm 932.Each latch 934 includes a stop 936 at or near the portion of the latch934 furthest from the arm 932 to which is it connected. The stops 936prevent the arms 932 from spreading apart from one another as far asthey would absent the presence of the stops 936, such as by overlappingone another. That is, each stop 936 is further from its associated arm932 than the stop 936 associated with the opposite arm 932, and extendsin a direction toward the other stop 936; as a result, the stops 936contact one another as the arms 932 move apart. Such contact preventsfurther motion of the arms 932 away from one another. Because the arms932 are biased apart from one another, the neutral position of theapplier 930 is that in which the stops 936 are in contact with oneanother.

Optionally, at least one alignment guide 938 extends from each arm 932toward the opposite arm 932. The alignment guides 938 may extend farenough to be at least partially adjacent to one another. This adjacentpositioning of the alignment guides 938 prevents or minimizes lateralmotion of the arms 932 relative to one another as the applier isactuated. That is, any lateral motion of one alignment guide 938 towardthe other is prevented or minimized by contact between the alignmentguides 938.

Optionally, a bump 940 is provided on at least one latch 934 between thestop 936 on that latch 934 and the arm 932 to which the latch isconnected. The bump 940 is spaced apart from the stop 936 far enoughsuch that an edge of the other stop 936 is held between the bump 940 andthe stop 936. As a result, interference prevents or restricts motion ofone stop 936 from moving beyond the bump 940 or the other stop 936. Thebump 940 and/or the stop 936 restrained by it are shaped such that apreselected force can overcome the interference between them and allowthe applier 930 to close. For example, the edge of the stop 936 may beangled, and/or the bump 940 may be rounded. By preventing or restrictingmovement of the arms 932 together, the applier 930 is in a known initialconfiguration when it is first taken in hand by the surgeon.

A holder 942 is located at the distal end of each arm 932. Alternately,at least one holder 942 is located in a different position relative tothe corresponding arm 932. At least one holder 942 is configured toengage a sealer 780. In FIG. 136, the sealer is a clip 800 such as shownin FIGS. 137-138, and the applier 930 and its use are described withreference to the clip 800. However, a different clip 800, or a sealer780 other than a clip could be used, if desired. The holder or holders942 may engage the clip 800 in any suitable manner. As one example, eachholder 942 may include a channel 944 defined therein, where that channel944 is sized to hold at least part of the clip 800. At least one channel944 may be sized to provide a pressure fit with the clip 800. The clip800 may be held in place by force exerted by the holders 942 toward oneanother. That is, where the bump 940 is utilized to hold the applier 930in an initial configuration, that initial configuration may be selectedsuch that the distance between the holders 942 is slightly less than thewidth of the clip 800 held therebetween. In this way, the holders 942exert force on the clip 800 and hold it securely in place prior to useby the surgeon. Optionally, the holders 942 and/or the clip 800 mayinclude a roughened or otherwise frictionally-enhanced surface at one ormore points of contact therebetween, in order to hold the clip 800 inplace more securely. Alternately, the clip 800 may flex during assembly,then spring back against the holders 942.

The clip 800 may be shaped and sized in any suitable manner. As oneexample, the clip 800 may have two prongs 946 connected at theirproximal ends. The proximal portions of the prongs 946 may form aV-shape. Moving distally, at least one prong 946 may bend to form anL-shape at its distal end, such that the distal end 948 of at least oneprong 946 may be oriented toward the other prong 946. The distal end ofeach prong 946 may be pointed or sharpened. The distal ends of theprongs 946 may be asymmetrical. That is, the distal end of one prong 946may be pointed, and while oriented toward the other prong 946, may becloser to the proximal end of the clip 800 than the distal end of theother prong 946. This asymmetry may facilitate closure of the clip 800,as described in greater detail below.

Referring also to FIG. 139, to operate the applier 930, the surgeongrasps it by hand or with a tool such as a forceps 950, and places itsdistal end in proximity to the anvil entry hole 584. Advantageously, theapplier 930 is positioned such that the distal ends 948 of the prongs946 of the clip 800 are on substantially opposite sites of the anvilentry hole 584. Further, where the distal ends of the prongs 946 of theclip 800 are substantially L-shaped, the applier 930 can place the clip800 in contact with the target vessel 580 without puncturing the targetvessel 580.

When the surgeon is satisfied with the placement of the distal end ofthe applier 930, compressive force is applied to the arms 932. Where thebump 940 is used, this compressive force overcomes the interferencebetween the bump 940 on one latch 934 and the stop 936 on the otherlatch 934, causing the distal ends of the arms 932 to move toward oneanother. As the distal ends of the arms 932 move closer together, theholders 942 move closer together, thereby applying compressive force tothe clip 800. As the holders 942 continue to compress the clip 800, thedistal ends 948 of the prongs 946 move closer together, until the clip800 is closed, such as shown in FIG. 138. Where the distal ends 948 ofthe prongs 946 are asymmetrical, the distal ends 948 may substantiallyengage one another, rather than passing by one another. In this way, theclip 800 may form a substantially continuous closed path along itsperimeter in the closed position, which may be advantageous for closureof the anvil entry hole 584. Alternately, the clip 800 may have adifferent configuration in the closed position. After the clip 800 isclosed, the surgeon releases the applier 930. Because the arms 932 arebiased apart from one another, the arms 932 move apart from one another,the holders 942 release the now-closed clip 800, and the anvil entryhole 584 is closed.

As another example, referring to FIG. 157, the clip 800 may be shapeddifferently. Such a clip 800 is asymmetrical. The clip 800 may include aneedle segment 1100 at one end thereof, where that needle segment 1100has a free end 1102. The free end 1102 of the needle segment 1100 isalso one end of the clip 800. The free end 1102 may be sharpened tofacilitate penetration of tissue. Moving along the clip 800 away fromthe free end 1102, a central segment 1104 of the clip 800 is connectedto the needle segment 1100. The central segment 1104 may be angledrelative to the needle segment 1100 at any suitable angle. For example,the central segment 1104 may be oriented at substantially a right angleto the needle segment 1100.

Optionally, a first tab 1106 may extend inward from the central segment1104 of the clip 800. Alternately, the first tab 1106 may extend inwardfrom the needle segment 1100 or a different segment of the clip 800.Alternately, the first tab 1106 may be omitted altogether. Optionally, asecond tab 1108 may extend outward from the central segment 1104 of theclip 800. Alternately, the second tab 1108 may extend outward from theneedle segment 1100 or a different segment of the clip 800. Alternately,the second tab 1108 may be omitted altogether.

Moving along the central segment 1104 away from the free end 1102, thecentral segment 1104 may angle or curve further. Optionally, at leastone indentation 1110 may be defined in the central segment 1104 and/oranother segment of the clip 800 in order to define a preferred bendingdirection and/or increase the amount of bending of which the clip 800 iscapable. Optionally, a third tab 1112 may extend outward from thecentral segment 1104. The third tab 1112 may be positioned on the otherside of the tabs 1106, 1108 from the needle segment 1110. Alternately,the third tab 1112 may be positioned differently. Alternately, the thirdtab 1112 may extend from a different segment of the clip 800. The clip800 may be restrained between the holders 942 by contact between thesecond tab 1108 and the notch 1120 of one holder 942, and contactbetween the third tab 1112 and a surface 1122 on the other holder 942adjacent to an end of the channel 944 defined therein.

Moving along the clip 800 away from the free end 1102, a third segment1114 of the clip 800 is connected to the central segment 1104. The thirdsegment 1114 may be angled relative to the central segment 1104 at anysuitable angle. For example, the third segment 1114 may angle backtoward the central segment 1104 to define an acute angle therewith.Alternately, the third segment 1114 may be oriented differently relativeto the central segment 1104. A tip 1116 may be formed at theintersection between the third segment 1114 and the central segment1104. The tip 1116 may be substantially sharp or substantially blunt.The free end 1118 of the third segment 1114 may be blunt and/or curved.Alternately, the free end 1118 of the third segment 1114 may be sharp.The clip 800 may be fabricated from a single unit of material, such thatthe segments 1100, 1104, 1114 thereof are simply portions of an integralclip 800. Alternately, at least one of the segments 1100, 1104, 1114 isfabricated separately and connected to one of the others in any suitablemanner, such as by welding.

Optionally, referring also to FIG. 158, the applier 930 may beconfigured differently to hold and deploy the clip 800 of FIG. 157. Asone example, one of the holders 942 may include a notch 1120 configuredto receive the second tab 1108. As another example, the channel 944 inone of the holders 942 may be oriented such that the third tab 1112encounters a surface 1122 on the holder 942 adjacent to the channel 944.A portion of the central segment 1104 of the clip 800 between the thirdtab 1112 and the third segment 1114 may reside within the channel 944.

To deploy the clip 800 of FIG. 157, the applier 930 of FIG. 158 isoperated substantially as described above. For brevity, only thesignificant differences in operation are described here. The surgeoninserts the free end 1102 of the needle segment 1100 into the tissue ofthe target vessel 580 on one side of the anvil entry hole 584. Then, thesurgeon moves the needle segment 1100 through the lumen of the targetvessel 580 across the width of the anvil entry hole 584, poking the freeend 1102 of the needle segment 1100 back out of the wall of the targetvessel 580 on the other side of the anvil entry hole 584. This motionmimics the motion that the surgeon would use to close the anvil entryhole 584 with a needle and suture. The needle segment 1100 can beremoved from the target vessel 580 and repositioned if the surgeon isnot satisfied with its placement.

When the surgeon is satisfied with the placement of the distal end ofthe applier 930, compressive force is applied to the arms 932, causingthe distal ends of the arms 932 to move toward one another. As thedistal ends of the arms 932 move closer together, the holders 942 movecloser together and exert a compressive force on the clip 800. The notch1120 in one holder 942 holds at least part of the second tab 1108 of theclip 800, and the third tab 1112 contacts the surface 1122 on the otherholder 942 adjacent to an end of the channel 944 defined therein,thereby substantially preventing the clip 800 from sliding out frombetween or rotating relative to the holders 942 as they move closertogether. The clip 800 may bend about the indentation 1110 in thepreferred bending direction established by the indentation 1110. As theholders 942 continue to move closer together, the notch 1120 still holdsat least part of the second tab 1108 of the clip 800. However, as theclip 800 bends about the indentation 1110 or other location, and thearms 932 of the applier 930 move about the location of their connectionto one another, the relative position of the third tab 1112 and thesurface 1122 changes. The third tab 1112 slides along the surface 1122and into the channel 944. The channel 944 in combination with the notch1120 still hold the clip 800 between the holders 942; however, thecentral member 1104 is now free to slide within the channel 944.

Referring to FIG. 159, after the clip 800 has been bent to a closedposition, the surgeon releases pressure on the arms 932 of the applier930. The holders 942 then move apart from one another. The second tab1108 of the clip 800 moves out of the notch 1120 in one holder, and thecentral member 1104 of the clip 800 moves out of the channel 944 in theother holder 942. The clip 800 is thus freed. Referring also to FIG.160, in the closed position in tissue, the clip 800 substantially closesthe anvil entry hole 584. As the clip 800 is moved to the closedposition, the tip 1116 at the intersection between the third segment1114 and the central segment 1104 engages the tissue of the targetvessel 580 on one side of the anvil entry hole 584 and pulls that tissuetoward the other side of the anvil entry hole 584, substantially closingit. The tip 1116 may engage the tissue of the target vessel 580 bypenetrating into or completely through the wall of the target vessel580. When the clip 800 is in the closed position, the first tab 1106 mayact to shield the tip 1116 and/or to hold tissue of the target vessel580 between itself and the tip 1116. When the clip 800 is in the closedposition, at least part of the third segment 1114 may act to shield thefree end 1102 of the needle segment 1100 and/or to hold tissue of thetarget vessel 580 between itself and the needle segment 1100.

The clip 800 may be shaped in any other suitable manner orconfiguration, and may be fabricated from any suitable material in anymanner. As one example, the clip 800 may be laser-cut or stamped from asheet of metal such as stainless steel. As another example, the clip 800may be a wire segment having any suitable cross section. As anotherexample, one or more cutouts or notches may be provided in the clip 800to establish a preferred bending direction of some or all of the clip800. The clip 800 may be configured such that at least one end of theclip 800 encounters a holder 942 or other part of the applier 930 duringits deployment, where that encounter deforms at least part of the clip800.

Operation of Other Exemplary Cutters

As described above, the cutter 200 incises the wall of the target vesselwhile the staple holder 38 is stapling or otherwise connecting the graftvessel to the target vessel, as described in greater detail below.Alternately, the staple holder 38 may completely staple or otherwiseconnect the graft vessel to the target vessel before the cutter 200 isurged forward, such that the two vessels are connected before the cutter200 makes an incision between them. Alternately, the cutter 200 incisesthe wall of the target vessel before the staple holder 38 has stapled orotherwise connected the graft vessel to the target vessel.

Referring to FIG. 49, a different embodiment of the anvil 10 alsoincludes a cutter 200 moveable relative to the anvil 10 for making anincision in the wall of a target vessel. The anvil 10, anvil arm 14,staple holder 38, and other components are substantially as describedabove with regard to FIGS. 34-38 and 44-49. In this embodiment, at leastthe distal end of the cutter 200 is biased upward. In other regards, theactuation of the anastomosis tool 300, the operation of the mechanismswithin the handle 302, and the operation of the tissue effector 400 aresubstantially as described above. Referring to FIGS. 35 and 49, an anvilinsert 222 may be connected to the anvil 10. If so, an aperture 230 isdefined through the distal end of the anvil insert 222 into the cavity228 defined within the anvil insert 222, connecting the channel 246 tothe cavity 228. The cutter 200 extends through the aperture 230 in theanvil insert 222, such that the distal end of the cutter 200 ispositioned within the channel 246 and the proximal end of the cutter 200is positioned within the cavity 228. A cam 232 is positioned within thecavity 228 above the aperture 230. Alternately, the cam 232 may bepositioned differently relative to the aperture 230. The cam 232 is astructure used in controlling the motion of the cutter 200, as isdescribed in greater detail below.

At least the distal end of the cutter 200 may be biased upward. Thisbiasing may be performed by any appropriate structure or mechanism, suchas by one or more springs (not shown). Such a spring or springs may actin compression to push the distal end of the cutter 200 upward, or mayact in tension to pull the distal end of the cutter upward. As anotherexample, the cutter 200 may be constructed from an elastic orsuperelastic material that is formed in such a way as to produce anupward bias. The entire cutter 200 may be biased upward, if desired. Atleast the distal end of the cutter 200 is biased upward during thetranslation of the cutter 200 along the anvil arm 14. Alternately, thecutter 200 is not biased, either upward or downward. Instead, the cutter200 is urged upward and downward at different locations during itstranslation by the interaction between at least one cam follower on thecutter 200 and at least the cam 232. As described above with regard tothe embodiment of the anvil 10 in which the cutter 200 is biaseddownward, optionally a shield 290 may be connected to the anvil 10. Theshield 290 is constructed and is operated substantially as describedabove.

As shown in FIG. 49, the distal end of the anvil arm 14 is spaced apartfrom the staple holder 38. The anvil arm 14 is inserted through the wallof the target vessel, as described above, such that the contact surface206 of the anvil arm 14 is in substantial contact with the inner wall ofthe target vessel. Next, referring to FIG. 50, the staple holder 38 andanvil 10 are moved relative to one another into the standby position, asdescribed above. In the standby position, the cutter 200 is freed fortranslation along the channel 246, because the tip 212 of the safetyfeature 210 no longer engages the safety recess 214 of the cutter 200.At least the distal end of the cutter 200 is biased upward, and the cam232 limits the upward motion of the cutter 200 by contacting at least aportion of the upper surface 252 of the cutter 200. The cam 232 controlsthe motion of the distal end of the cutter 200 in the vertical directionas the cutter 200 translates within the channel 246. Because theprojection 208 is fixed to the cutter 200, the cam 232 also controls themotion of the projection 208 in the vertical direction, and thuscontrols the location at which the projection 208 encounters the wall ofthe target vessel.

Referring also to FIG. 51, after the cutter 200 has been freed fortranslation, it is urged distally by the receiver 218 as describedabove. A first cam follower 242 is defined on the upper surface 252 ofthe cutter 200. The first cam follower 242 is a raised structure formedinto the upper surface 252 of the cutter 200. Alternately, the first camfollower 242 is a separate structure or mechanism constructed separatelyfrom the cutter 200 and later connected to the cutter 200. Alternately,the first cam follower 242 may be located on a surface of the cutter 200in addition to or instead of its upper surface 252, depending on theposition and configuration of the cam 232. The first cam follower 242may be shaped as a trapezoid or similar shape, or may be shapeddifferently.

The cam 232 is fixed, and the first cam follower 242 is raised relativeto the upper surface 252 of the cutter 200. At least the distal end ofthe cutter 200 is biased upward. Thus, as the cutter 200 translatesdistally, the cam 232 engages the first cam follower 242 and causes thecutter 200 to move downward. The cam 232 and the first cam follower 242are shaped to smoothly engage each other. Alternately, the first camfollower 242 is shaped to induce the cutter 200 to abruptly movedownward when the first cam follower 242 initially encounters the cam232. The height of the first cam follower 242 relative to the contactsurface 206 of the anvil arm 14 determines the distance that the distalend of the cutter 200 is moved downward. As described above, the cutter200 may include a keel 264 or similar projection extending downward. Asthe distal end of the cutter 200 moves downward, the keel 264 or otherprojection moves into the first lower opening 254. In this embodiment,the first lower opening 254 does not control the motion of the cutter200; instead, it provides a space for the keel 264 to move downwardwithout interfering with the vertical motion of the distal end of thecutter 200. If the keel 264 is omitted, the first lower opening 254 andthe second lower opening 268 may be omitted as well.

The connection between the graft vessel and the target vesselsubstantially defines a closed area, and the projection 208 isconfigured to engage the wall of the target vessel within that closedarea. That is, the end of the graft vessel has a perimeter that contactsthe side of the target vessel, such that the perimeter of the end of thegraft vessel defines a closed area on the wall of the target vessel. Inthis way, the projection 208 makes an incision completely within theconnection between the graft vessel and the target vessel, completingthe anastomosis between the two vessels and minimizing or eliminatingleakage at the anastomosis site. While the projection 208 on the cutter200 remains below the contact surface 206 of the anvil arm 14, itneither engages nor cuts the wall of the target vessel. Thus, the firstcam follower 242 is sized to translate the tip of the projection 208below the contact surface 206 of the anvil arm 14 for a selecteddistance such that the projection 208 does not engage the tissue of thetarget vessel until the projection 208 is positioned to enter the closedarea on the wall of the target vessel defined by the perimeter of theend of the graft vessel.

Referring also to FIG. 52, the cutter 200 continues to advance distallyas the receiver 218 continues to impel the engagement feature 216distally. Thus, the first cam follower 242 of the cutter 200 advancesdistally relative to the cam 232. As described above, at least thedistal end of the cutter 200 is biased upward. The first cam follower242 decreases in height at its proximal end. Thus, as theupwardly-biased first cam follower 242 moves distally relative to thecam 232, the cam 232 and the first cam follower 242 gradually disengage,causing both the distal end of the cutter 200 and the projection 208 tomove upward. The first cam follower 242 is constructed to provide asmooth, gradual upward motion of the distal end of the cutter 200 andthe projection 208, such as by providing a gradual slope between anupper surface 250 of the first cam follower 242 and an upper surface 252of the cutter 200. Alternately, the first cam follower 242 may beconstructed to allow the distal end of the cutter 200 and the projection208 to abruptly snap upward as the first cam follower 242 moves distalto the cam 232.

As the distal end of the cutter 200 moves upward, the projection 208moves upward through the upper opening 248 in the anvil arm 14. Thecontact surface 206 of the anvil arm 14 is adjacent to the inner surfaceof the wall of the target vessel. Thus, upward motion of the projection208 through the upper opening 248 causes the projection 208 to enter thewall of the target vessel. The projection 208 is sized, and the firstcam follower 242 and cam 232 are shaped, such that the upward motion ofthe projection 208 after the first cam follower 242 has moved distal tothe cam 232 causes the projection 208 to completely penetrate throughthe wall of the target vessel. That is, at least a portion of theprojection 208 passes through the wall of the target vessel and entersthe lumen. This initial penetration of the wall of the target vesseldefines the starting point of an arteriotomy performed on the targetvessel by the projection 208. The starting point of the arteriotomy isspaced apart from the location on the target vessel at which the anvilarm 14 is inserted, resulting in a tissue bridge therebetween.

Referring also to FIG. 53, the cutter 200 continues to advance distallyas the receiver 218 continues to impel the engagement feature 216distally. The upper surface 252 of the cutter 200 may contact the cam232 during this motion, because the distal end of the cutter 200continues to be biased upward. As the cutter 200 translates, theprojection 208 moves through the tissue of the wall of the target vesselin a direction substantially parallel to the longitudinal centerline ofthe anvil arm 14. In this way, the projection 208 incises the tissue ofthe wall of the target vessel to create an arteriotomy. The tip of theprojection 208 may maintain substantially the same height relative tothe contact surface 206 of the anvil arm 14 during its distaltranslation, or may change its height relative to the contact surface206 of the anvil arm 14, as long as the tip of the projection 208remains in the lumen of the target vessel during that translation.

Referring also to FIG. 54, a second cam follower 244 is defined on theupper surface 252 of the cutter 200, proximal to and spaced apart fromthe first cam follower 242. Alternately, a single cam follower isdefined on the upper surface 252 of the cutter 200, where that singlecam follower includes a feature corresponding to the first cam follower242, a feature corresponding to the second cam follower 244, and asection of reduced height between them corresponding to the uppersurface 252 of the cutter 200. The cutter 200 continues to advancedistally as the receiver 218 continues to impel the engagement feature216 distally. As a result of this motion, the second cam follower 244contacts the cam 232. Engagement between the second cam follower 244 andthe cam 232 pushes the distal end of the cutter 200 downward. The shapeand size of the second cam follower 244 and cam 232 are selected suchthat the distal end of the cutter 200 is pushed downward far enough tocause the projection 208 to retract into the upper opening 248. Theprojection 208 may be urged downward completely into the channel 246,depending on the depth of the channel 246 and the height of theprojection 208. Alternately, the upper tip of the projection 208 mayremain within the upper opening 248. The cutter 200 may stop its distaltranslation at substantially the same time that the projection 208retracts completely into the upper opening 248, or may continue totranslate distally within the channel 246 before coming to a stop.

When the projection 208 is retracted out of the tissue of the wall ofthe target vessel, the distal end of the arteriotomy is defined, and thearteriotomy is complete. The distance between the first cam follower 242and the second cam follower 244, and the shape of the cam followers 242,244, determine the length of the arteriotomy. That is, each cam follower242, 244 includes a location thereon having a height relative to theupper surface 252 of the cutter 200 sufficient to cause the projection208 to be pushed out of contact with the wall of the target vessel. Thedistance between these locations defines the length of the arteriotomy.Thus, the cam followers 242, 244 control the motion of the projection208 and control the penetration of the wall of the target vessel.

After performing the arteriotomy, the cutter 200 is in adistally-extended position. The cutter 200 remains in that position asthe anvil arm 14 is removed from the target vessel. Alternately, afterperforming the arteriotomy, the cutter 200 may be moved proximallywithin the channel 246 before removing the anvil arm 14 from the targetvessel. The anvil arm 14 is removed from the target vessel after theanastomosis between the graft vessel and the target vessel has beencompleted. The anvil entry hole 584 and its closure are substantially asdescribed above.

Alternately, the cutter 200 is initially in a distally-extendedposition, and retracted proximally in order to make an incision in thewall of the target vessel. Similarly, the sled 482 is initially at itsmost distal location. The structures and mechanisms are substantially asdescribed above, but operated in substantially the reverse order asdescribed above. In this embodiment, the channels 496 in the stapleholder 38 are not needed, nor it is necessary to reverse the directionof motion of the second cable 490 as applied to the sled 482; rather,the sled 482 is deployed by pulling it proximally with the second cable490. Thus, the second cable 490 may be connected to the proximal end orother portion of the sled 482. Alternately, the cutter 200 and theprojection 208 may be moved in a different way in order to incise thetissue of the wall of the target vessel. Further, this embodiment isparticularly suited for the use of a cutter 200 having a sharp distalend that initially extends out of the distal end of the anvil arm 14 inorder to puncture the target vessel, after which the cutter 200 isretracted proximally to move its sharp distal end into the anvil arm 14.

Where multiple projections 208 are provided on the cutter 200 as shownin FIGS. 39-43, the cutter 200 need not be translated as far to make anincision in the wall of the target vessel as it would if only a singleprojection were used. Because the projections 208 are spaced apart fromeach other along the direction of translation of the cutter 200, eachprojection 208 is able to form a portion of the incision duringtranslation of the cutter 200. Thus, by translating each projection 208across a distance less then the intended length of the entire incision,the complete incision can be formed. The distance that the cutter 200 istranslated to form the incision is related to the distance between theprojections 208. That is, because each projection 208 forms a portion ofthe incision, no single projection 208 need be translated along theentire length of the incision.

Alternately, where multiple projections 208 are utilized, theprojections 208 may be inserted into the wall of the target vessel,after which energy is applied to the projections 208 via the cutter 200or directly in order to create an incision in the wall of the targetvessel. In such an embodiment, an energy source (not shown) is connectedto the cutter 200. For example, an ultrasound generator (not shown) maybe connected to the cutter 200 and to the energy source. The ultrasoundgenerator may be a piezoelectric crystal, as is standard, or a differentstructure or mechanism. Electrical energy may be applied to theultrasound generator from the energy source, thereby causing theultrasound generator to vibrate the projections 208. Thus, energy may beapplied from the energy source to the ultrasound generator after theprojections 208 have been inserted into the wall of the target vessel,causing the projections 208 to move and thereby create an incision.Advantageously, a plurality of projections 208 spaced relatively closeto one another are utilized. Other methods may be used to vibrate, moveor oscillate the projections 208. Alternately, energy may be applied tothe cutter 200 to form an opening in the wall of the target vessel 580even if the cutter 200 has no projections 208 at all.

Adjustable Staple Line and Target Vessel Opening Size

Alternately, the length of the arteriotomy created by and the number ofconnectors 464 deployed by the tissue effector 400 are adjustable. Bycontrolling these parameters, graft vessels of different diameters canbe attached to a target vessel within a small range of angles relativeto the graft vessel. The cross-sectional area of the connection betweenthe graft vessel and the target vessel thus can be controlled across arange of two or more sizes while providing for a substantially fixedangle between the target vessel and the graft vessel.

The number of connectors 464 deployed by the tissue effector 400 can becontrolled in any appropriate manner. Referring also to FIGS. 111-113,an example of a staple holder 38 configured to deploy a selectablenumber of connectors 464 is shown. This staple holder 38 is similar tothe embodiments described above, such as with regard to FIGS. 56-58 and64; for clarity and conciseness, only the significant differences aredescribed here. The staple holder 38 includes a cap 810 movable relativeto at least one arm 402 of the staple holder 38. For example, the cap810 may be slidable relative to at least one arm 402 of the stapleholder 38. For compactness, the cap 810 may be, at least in part, thinand substantially conformal to the exterior shape of the remainder ofthe staple holder. However, the cap 810 may be shaped in any appropriatemanner. As one example, the cap 810 includes two members 812 eachextending distally from a body 814. At least one member 812 may have aC-shaped or U-shaped cross-section at least in part, such that at leastone member 812 is configured to slide along an outer lateral, surface ofa corresponding arm 402 of the staple holder 38. The C-shaped orU-shaped cross section of at least one member 812 may restrict orsubstantially prevent lateral motion of the cap 810 relative to thestaple holder 38 to guide the motion of the cap 810 longitudinally.Alternately, at least one member 812 may have a different cross section.Similarly, the body 814 may have a C-shaped or U-shaped cross sectionthat facilitates the sliding of the cap 810 relative to the stapleholder 38, and assists in holding the cap 180 on the staple holder 38.Alternately, the body 814 may have a different cross-section.

The cap 810 includes at least one control element 816 that is connectedto the body 814 or that is part of the body 814. Alternately, thecontrol element or elements 816 may be connected to at least one member812. The control element 816 provides positive control over thelongitudinal position of the cap 810 relative to the staple holder 38.As one example of a control element 816, two legs 818 extend laterallyand downward from a proximal part of the upper portion of the body 814,and are compressible toward one another. Lateral force exerted on aportion of the legs 818 in proximity to the lower portion of the stapleholder 38 thus may cause lateral motion of the legs 818. Each leg 818may wrap around a side of the staple holder 38 to the underside of thestaple holder 38, substantially conforming to the shape of the stapleholder 38. Advantageously, the legs 818 are not connected to each otheron the underside of the staple holder 38. The portion of each leg 818located in contact with or in proximity to the underside of the stapleholder 38 may be characterized as the foot 820 of that leg 818.

Each foot 820 includes at least one registration feature 822. As oneexample, at least one foot 820 may include an aperture 824 therethroughor therein, where an edge of that aperture 824 includes at least oneregistration feature 822 such as an indentation. At least one post 826or other structure or mechanism may extend from the underside of thestaple holder 38 into the aperture 824. Each post 826 is substantiallyfixed to the staple holder 38. Each post 826 is configured to engage aselected one of the registration features 822, which are spaced apartfrom one another by a distance substantially equal to the spacingbetween the connectors bays 448. The registration features 822 of eachfoot 820 may be positioned on the edge of the aperture 824 closest tothe longitudinal centerline of the staple holder 38. Correspondingly,each post 826 may be positioned relative to the corresponding foot 820such that each post 826 engages a registration feature 822 when the legs818 are not compressed together, and such that the registration features822 are moved out of engagement with the posts 826 when the legs arecompressed together. The cap 810 is thus movable to a selected one of anumber of positions relative to the staple holder 38, where the numberof positions is equal to the number of registration features 822. Eachdiscrete position corresponds to the release of a particular number ofconnectors 464, as described in greater detail below.

At least one member 812 of the cap 810 includes a first tab 828extending at least partially inwardly therefrom. At least one arm 402 ofthe staple holder 38 includes a trough 830 or similar structure alongwhich the first tab 828 is configured to translate substantiallylongitudinally. Optionally, at least one member 812 also includes asecond tab 832 extending at least partially inwardly therefrom. Thesecond tab 832 may be positioned proximal to and near the first tab 828.However, the second tab 832 may be positioned differently relative tothe first tab 828. The second tab 832 is configured to travel along asurface 834 of the staple holder 38 that is located above the trough830. The second tab 832 may assist in guiding the motion of the firsttab 828 along the trough 830.

Referring also to FIGS. 113-114, the staple holder 38 includes a numberof connector bays 448 defined in each arm 402 of the staple holder 38,as described above. At least one of the connector bays 448 in each arm402 of the staple holder 38 holds a split deployer 836. Each splitdeployer 836 is switchable between a state in which it can deploy acorresponding connector 464 and a state in which it cannot deploy acorresponding connector 464. At least one additional connector bay 448in at least one arm 402 of the staple holder 38 may hold a connectordeployer 452 configured as described above. Connector deployers 452 maybe used along a length of the arm 402 that corresponds to the smallestanastomosis to be performed with the tissue effector 400, whichcorresponds to the smallest size of the graft vessel 404 to be used. Thesplit deployers 836 may be used along a length of the arm 402 thatcorresponds to larger sizes of graft vessel 404.

The split deployer 836 includes a pin 838 that connects a first driverelement 840 to a second driver element 842. The first driver element 840is located above the second driver element 842; however, they may bepositioned differently relative to one another. The pin 838 extendsthrough an aperture 844 in the first driver element 840 and through anaperture (not shown) in the second driver element 842. Alternately, thesecond driver element 842 includes a recess defined therein, rather thanan aperture defined completely therethrough. Advantageously, the pin 838is oriented in a direction substantially perpendicular to the directionof travel of the split deployer 836. However, the pin 838 may beoriented in a different direction if desired. The pin 838 is used totransmit force between the first driver element 840 and the seconddriver element 842. Alternately, a structure or mechanism other than thepin 838 is used to transmit force between the elements 840, 842.

The pin 838 is movable relative to both the first driver element 840 andthe second driver element 842, in a direction substantially along itsaxis. The pin 838 is movable between a first position in which noportion thereof is located within the second driver element 842, and asecond position in which a portion thereof is located within both thefirst driver element 840 and the second driver element 842. Referringalso to FIG. 69, as described above, the distal end 474 of the rampelement 446 is configured to engage the connector deployers 452 as itmoves, causing those connector deployers 452 in turn to translate orotherwise move relative to their respective connector bays 448. Thesplit deployers 836 and/or the connector bays 448 that hold them areconfigured such that the distal end 474 of the ramp element 446 contactsonly the first driver element 840 and not the second driver element 842.Further, only the second driver element 842 contacts the connector 464.Thus, in order for motion of the ramp element 446 to cause deployment ofa connector 464 from a split deployer 836, the driver elements 840, 842are first connected such that force can be transmitted therebetween.When the pin 838 is located in the first position, the first driverelement 840 moves when the distal end 474 of the ramp element 446engages it, but the second driver element 842 does not move, because thepin 838 is not located in the aperture or recess in the second driverelement 842 and thus cannot transmit force to the second driver element842. As a result, the second driver element 842 does not move and thecorresponding connector 464 is not deployed. When the pin 838 is in thesecond position, the first driver element 840 moves when the distal end474 of the ramp element 446 engages it. The pin 838 extends through theaperture 844 in the first driver element 840 and into the aperture orrecess of the second driver element 842. As a result, the pin 838couples the elements 840, 842, thereby causing the second driver element842 to move along with the motion of the first driver element 840. As aresult, the second driver element 842 deploys the correspondingconnector.

Prior to the motion of the ramp element, the pin 838 may be in the firstposition. The pin 838 may be held in or biased to the first position inany appropriate manner. As one example, the pin 838 has a diametersubstantially equal to the diameter of the aperture 844 in the firstdriver element 840. Thus, the surface of the pin 838 is substantially incontact with the walls of the aperture 844, and that contact results ina frictional force. That frictional force is chosen, such as by theselection of materials and the manufacturing tolerances utilized, suchthat the pin 838 is held securely in the first position prior to itsmotion to the second position. Such motion is caused by a force having amagnitude selected such that it overcomes the frictional force betweenthe pin 838 and the walls of the aperture 844. As another example, abarrier (not shown) is located at the bottom end of the aperture 844.This barrier may include one or more frangible members, a membrane, aplug of material, or any other appropriate structure or mechanism. Thebarrier is strong enough to hold the pin 838 in the first position priorto motion of the pin 838 to the second position. Such motion is causedby a force having a magnitude selected such that it breaks, penetrates,shears or otherwise passes through or around the barrier. As anotherexample, the pin 838 is biased to the first position, such as by aspring (not shown) within the aperture 844 of the first driver element840.

One or more attachment elements, such as the spikes 410 described above,extend from the underside of the staple holder 38 and are substantiallyfixed relative to the staple holder 38. Advantageously, two spikes 410are provided, each on a different arm 402 at or near its proximal end.Alternately, more than two spikes 410 are utilized. Alternately, one ormore attachment elements other than spikes 410 may be utilized, such asclips. In addition, one or more movable attachment elements 846 areconnected to or formed into at least one member 812 of the cap 810, suchas on the lower surface of that member 812. Each movable attachmentelement 846 may be fixed to the corresponding member 812 of the cap 810and thereby movable relative to the staple holder 38. The movableattachment elements 846 may be located distal to the spikes 410 fixed tothe staple holder 38. Alternately, the movable attachment elements 836and the spikes 410 are positioned differently relative to one another.Each movable attachment element 846 may be a spike, clip or any otherappropriate structure or mechanism.

Other than controlling the number of connectors 464 deployed, the tissueeffector 400 operates substantially as described above. In the interestof clarity and conciseness, only the significant differences aredescribed here. Each flap 408 in the graft vessel 404 is initiallyplaced onto and poked down on at least one corresponding spike 410,where each spike 410 is substantially fixed relative to the stapleholder 38. Where the spike or spikes 410 are located closer to theproximal end of each member 812, a proximal portion of a correspondingflap 408 is engaged. Where the spike or spikes 410 are located closer tothe distal end of each member 812, a distal portion of a correspondingflap 408 is engaged. In this way, an end of each flap 408 is connectedto the staple holder 38 at a fixed location. Each flap 408 is not yetconnected to at least one corresponding movable attachment element 846.

The cap 810 is then moved relative to the staple holder 38, such as bytranslation. As shown, the cap 810 is positioned initially at a proximallocation, and is movable distally. The fixed spikes 410 are positionedproximal to the cap 810, and thus proximal to the movable attachmentelements 846 on the cap 810. As the cap 810 is moved distally, themovable attachment elements 846 move distally as well, increasing thespacing between each spike 410 and the corresponding movable attachmentelement 846. The user continues to move the cap 810 distally until themovable attachment elements 846 are close to the distal ends of theflaps 408. The motion of the cap 810 is then stopped by the user, andthe flaps 408 are pressed or otherwise brought into engagement with themovable attachment elements 846. In this way, the final position of thecap 810 is related to the width of the graft vessel 404, and may be saidto measure the width of the graft vessel 404. If the graft vessel 404has a width such that the movable attachment elements 846 are close tothe distal ends of the flaps 408 when the cap 810 is in its initialposition, then the cap 810 is not moved, and the initial position andthe final position of the cap 810 are the same. Alternately, the cap 810may be positioned initially at a distal location, and be movableproximally, where the spikes 410 fixed to the staple holder 38 areinitially located distal to the movable attachment elements 846. Wherethe cap 810 is utilized, the transfer clamp assembly 670 may be omitted.If so, the wings 760 of the staple holder 38 may be omitted, reducingits height as compared to other embodiments of the staple holder 38.Such a staple holder 38 may be characterized as having a low profile. Alow-profile staple holder 38 may facilitate access to more locations onthe heart, and may be better suited for closed-chest coronary arterybypass graft surgery, such as via an intercostal or sub-xyphoidincision, or other port in the patient's thoracic cavity.

In order to move the cap 810, the user manipulates its control section816. As one example, the legs 818 of the control section 816 arecompressed together. This compression moves at least one registrationfeature 822 in each foot 820 of the control section 816 out ofengagement with the corresponding post 826 connected to the stapleholder 38, freeing the cap 810. The cap 810 then is slid relative to thestaple holder 38. The post 826 remains within the aperture 824 in thefoot 820 as the cap 810 slides. Where two flaps 408 are utilized andeach flap 408 is penetrated near its proximal edge by at least one spike410, the cap 810 is slid along the staple holder 38 until each movableattachment element 846 is positioned close to the distal edge of thecorresponding flap 408. When each movable attachment element 846 ispositioned close to the distal edge of the corresponding flap 408, thelegs 818 are released, and at least one engagement feature 822 engagesthe corresponding post 826 on the staple holder 38. This engagementholds the cap 810 substantially motionless in its new position. At leastone movable attachment element 846 is then connected to each flap 408.

As the cap 810 is slid relative to the staple holder 38 to engage theflaps 408 with the movable attachment elements 846, each first tab 828slides along the corresponding trough 830. The upper end of each pin 838of each split deployer 836 extends upward into the corresponding trough830 when that pin 838 is in the first position. The upper end of eachpin 838, and/or the distal edge of each first tab 828, is shaped suchthat contact between a first tab 828 and a pin 838 urges the pin 838downward into engagement with the corresponding second driver element842. For example, the upper end of at least one pin 838 may be rounded,curved, angled, beveled or otherwise shaped such that the correspondingfirst tab 828 can smoothly engage it and press it downward as it movesalong the trough 830. As another example, the distal edge of at leastone first tab 828 may be beveled such that it can smoothly engage onepin 838 or a number of pins 838 in succession.

Each pin 838 is initially in the first position. When the first tab 828encounters a pin 838 and presses it downward, that pin 838 is moved tothe second position, in which a portion of the pin 838 is located withinthe first driver element 840 and a portion of the pin 838 is locatedwithin the second driver element 842. In the second position, the driverelements 840, 842 are coupled, as described above, and the splitdeployer 836 is said to be activated. The clearance between the firsttab 828 and the trough 830, and the length of the pin 838, are selectedto ensure that contact between the first tab 828 and the pin 838 urgesthe pin 838 into the second position. Alternately, one or more splitdeployers 836 may be actuated in a different manner.

The first tab 828 is sized such that it can cover or otherwise engage anumber of pins 838 up to the number of split deployers 836. In this way,motion of the first tab 828 relative to the pins 838 determines thenumber of pins 838 depressed, and thus the number of split deployers 836activated. In the embodiment shown, three split deployers 836 areutilized, and are located distal to the connector deployers 452. The cap810 is initially located in a proximal position, and is slid distally aspart of the measurement process. The first tab 828 is sized to engage upto three pins 838. In this way, motion of the cap 810 causes the firsttab 828 to activate up to all of the split deployers 836. Alternately,more or fewer than three split deployers 836 may be provided, and thefirst tab 828 is then sized accordingly.

A number of connector deployers 452 are provided, corresponding to aminimum size of the graft vessel 404. That is, where the graft vessel404 has a width such that the cap 810 is not moved before the flaps 408are connected to the spikes 410 and the movable attachment elements 846,the connector deployers 452 are positioned relative to the cap 810 andthe flaps 408 such that the flaps 408 are connected to the target vessel580 solely by deployment of connectors 464 by the connector deployers452; none of the split deployers 836 are actuated. The process of movingthe cap 810 automatically matches the number of split deployers 836actuated to the size of the flaps 408 of the graft vessel 404, and thusmatches the number of connectors 464 deployed to the size of those flaps408, eliminating the need to take a separate measurement. Further, bycontrolling the number of connectors 464 deployed to connect graftvessels 404 of different sizes to a target vessel 580, the angle betweenthe graft vessel 404 and the target vessel 580 can be substantially thesame for different widths of graft vessel 404. The number of connectors464 deployed, and not the angle of the graft vessel 404 relative to thetarget vessel 580, is controlled in order to accommodate graft vessels404 of different sizes.

The registration features 822 provide positive control over the positionof the cap 810 relative to the staple holder 38, and thus over theposition of the first tab 828 relative to the pins 838 of the splitdeployers 836. The registration features 822 are longitudinally spacedfrom one another, and that spacing corresponds to discrete longitudinalpositions of the cap 810 relative to the staple holder 38. Therefore,the longitudinal position of the cap 810 is controlled by selecting theparticular registration feature 822 to engage the corresponding post826. The first tab 828 is positioned on the cap 810 such that when thecap 810 is in the initial, proximal-most position and the post 826engages the most-distal registration feature 822, the first tab 828engages none of the pins 838 and thus actuates none of the splitdeployers 836. This position is utilized for the smallest diameter graftvessels 404. When the cap 810 is moved proximally such that the post 826engages the next most proximal registration feature 822, the first tab828 is in position to urge the pin 838 of the most proximal splitdeployer 836 downward and activate that split deployer 836. The numberof registration features 822 may correspond to the number of splitdeployers 836, such that the most-distal position of the cap 810 thatcorresponds to the engagement of the post 826 with the most-proximalregistration feature 822 places the first tab 828 in a position toengage all of the pins 838 and thus actuate all of the split deployers836. The registration features 822 ensure that the first tab 828 ispositioned accurately relative to the appropriate pin or pins 838. Inthis way, the registration features 822 provide positive control overthe number of split deployers 836 to be activated.

The tissue effector 400 is moved to the closed position, the anastomosistool 300 is actuated, and the sled 482 moves distally, substantially asdescribed above. The deployment of connectors 464 by connector deployers452 also proceeds substantially as described above. Referring also toFIG. 64, as the ramp element 446 moves distally and sequentiallycontacts the connector deployers 452, each connector deployer 452 isurged in turn into the corresponding connector bay 448, thereby urgingthe associated connector 464 out of the connector 448 and deploying thatconnector 464 into tissue to connect a flap 408 of the graft vessel 404to the wall of the target vessel 580.

As the sled 482 continues to move distally, each ramp element 446continues to move distally. For clarity of description, the motion andaction of one ramp element 446 is described; the other ramp element 446is understood to move and act in substantially the same manner. Thefirst driver element 840 of each split deployer 836 is initiallypositioned such that a portion thereof extends into the passage 440, asdescribed above with regard to the initial position of the connectordeployers 452. As the ramp element 446 moves distally, it sequentiallycontacts each first driver element 840 and urges it along thecorresponding connector bay 448. If a split deployer 836 is activated,such that the pin 838 extends between the driver elements 840, 842 orthe driver elements 840, 842 are otherwise connected, motion of thefirst driver element 840 under the influence of the ramp element 446 istransmitted to the corresponding second driver element 842. As thesecond driver element 842 moves along the connector bay 448, it deploysthe associated connector 464 in substantially the same manner asdescribed above with regard to the connector deployers 452. If a splitdeployer 836 is not activated, such that the pin 838 does not extendinto the second driver element 842 or otherwise connect the driverelements 840, 842, that motion of the first driver element 840 is nottransmitted to the corresponding second driver element 842. The seconddriver element 842 substantially does not move, and thus does not deploythe corresponding connector 464.

By arranging the split deployers 836 relative to the connector deployers452, graft vessels of different widths may be accommodated by deployingdifferent numbers of connectors 464. One or more split deployers 836 aregrouped together and provided on an arm 410 of the staple holder 38, andplaced either proximal or distal to one or more connector deployers 452which are also grouped together. Either the split deployers 836 or theconnector deployers 452 may be deployed first; the deployment order isdetermined by the direction in which the sled 482 translates and thepositional relationship between the split deployers 836 and theconnector deployers 452. As described above, the sled 482 may begin in amore-proximal location and translate distally to actuate the deployers452, 836, or the sled 482 may begin in a more-distal location andtranslate proximally to actuate the deployers 452, 836.

As with regard to the embodiment of the anastomosis tool 300 withoutsplit deployers 836, the sled 482 translates through a substantiallycomplete stroke regardless of the number of split deployers 836 thatwere actuated and the corresponding number of connectors 464 deployed bythose split deployers 836. That is, the number of connectors 464deployed is not related to the distance across which the sled 482translates, but rather to the actuation state of the split deployers836. Because the sled 482 translates through a substantially completestroke regardless of the number of split deployers 836 that areactuated, the cutter 200 may be configured to make an arteriotomy of astandard size that corresponds to the smallest graft vessel. In thisway, the length of the arteriotomy does not vary with the width of thegraft vessel 404.

However, the number of connectors 464 deployed and/or the length of thearteriotomy may be controlled by varying the length of stroke of thesled 482. If so, the split deployers 836 optionally may be omitted, andthe connector deployers 452 instead may be used in all of the connectorbays 448. As an example, by varying the stroke of the sled 482 andtherefore the length along each passage 440 that is traversed by thecorresponding ramp element 446 of the sled 482, the number of connectors464 deployed as a result of motion of the sled 482 can be controlled.The variable length of stroke of the sled 482 can be used to control themotion of the cutter 200 and thus vary the length of the arteriotomy tocorrespond to the width of the graft vessel 404. Control of the strokeof the sled 482 may be accomplished in any appropriate manner. Forexample, a control (not shown) connected to the handle 302 may allow theselection of a particular number of connectors 464 for deployment. Sucha control may interact with the second cable 490 and/or other componentsof or connected to the handle 302, in order to restrict the length thatthe second cable 490 moves upon actuation. By restricting the motion ofthe second cable 490, the stroke of the sled 482 is controlled, andhence the number of connectors 464 deployed is controlled. As anotherexample, a set of controllable stops (not shown) may be provided withinthe tissue effector 400. Each stop is positioned in proximity to aconnector bay 448, and is moveable between a first position that is outof the passage 440 adjacent to the connector bay 448 and a secondposition that is at least partially into the passage 440. In the secondposition, the stop contacts and prevents further distal motion of thecorresponding ramp element 446 of the sled 482. The control interactswith the stops, such that when the control is used to select aparticular number of connectors 464 for deployment, at least one stop ismoved to its second position into a passage 440 of the tissue effector400. Each stop that is moved to its second position corresponds to theconnector bay 448 from which the last of the selected number ofconnectors 464 is to be deployed. Other mechanisms, structures ormethods may be used to control the number of connectors 464 that aredeployed.

Similarly, the length of the arteriotomy is controlled to correspond tothe length of tissue that is connected by the selected number ofconnectors 464. The length of the arteriotomy can be controlled bycontrolling the motion of the cutter 200. The motion of the cutter 200can be controlled in several ways. As one example, the openings 254, 268in the anvil arm 14 can be changed both in length and position, toensure that the arteriotomy is made to the correct length in the correctposition. The openings 254, 268 can be changed in length and position inany appropriate manner. As one example, one or more pins or otherstructures (not shown) are extendable laterally across the openings 254,268, such that the presence of those pins or other structures across theopenings 254, 268 effectively changes their length and position. Othermechanisms, structures or methods may be used to control the length andposition of the openings 254, 268 and/or the motion of the cutter 200.

Additional Exemplary Tissue Effectors

FIGS. 17-23 illustrate an alternate anvil 100 that is used with a clamp102 for controlling an incision site during an anastomosis procedure. Asshown in FIGS. 17 and 18, the anvil 100 includes an anvil arm 104 and ahandle 106. The clamp 102 is slidable on the handle 106 to clamp thetissue of the target vessel 30 between the clamp 102 and the anvil arm104. As with the anvil arm 104 described above, the anvil arm 104includes two rows of staple bending features 108 in the form of recessespositioned in two parallel rows along a top surface of the anvil arm104. The clamp 102 has a central opening 110. Once the tissue of thetarget vessel wall has been trapped between the clamp 102 and the anvilarm 104, an incision may be made through the target vessel wall and theedges of the incision are controlled by the combination of the anvil arm104 and the clamp 102.

As shown in FIG. 19, a continuous anastomosis staple device 114 may beused to connect the graft vessel 32 to the target vessel 30 at theanastomosis site. The staple device 114 as shown in FIG. 19 includes aplurality of linkages forming a tubular configuration and a plurality ofstaple ends extending from the linkages. FIGS. 20-22 illustrate how thestaple ends 116 of the staple device 114 are positioned in the end ofthe graft vessel 32 and are inserted through the incision 118 in thetarget vessel and bent over by contact with the staple bending features108 of the anvil. As shown in FIG. 22, the opposite ends 120 of thestaple device 114 are folded over to complete the anastomosis. FIG. 23illustrates a completed anastomosis performed according to the stepsillustrated in FIGS. 19-22.

FIGS. 24-27 illustrate an alternate example of an anvil arm 14 d havinga cutting wire 124 for forming the incision in the wall of the targetvessel 30. The cutting wire 124 may be used to form an incision before,during or after performing an end-to-side anastomosis procedure.Referring particularly to FIGS. 26-27, for forming the incision afterthe anastomosis procedure, a clamp 126 is used to trap the tissue at theanastomosis site between the clamp 126 and the anvil arm 14 d prior toperforming the incision. The incision is spaced apart from the entrypoint of the anvil arm 14 d into the target vessel, creating a tissuebridge between the incision made in the wall of the target vessel andthe entry point of the anvil arm 14 d into the target vessel. A portionof the contact between the anastomosed graft vessel and target vesselextends across the tissue bridge, such that the incision is locatedwithin the closed area defined by the contact between the perimeter ofthe end of the graft vessel and the wall of the target vessel.

FIG. 28 shows a system 140 for controlling a tissue site and performinganastomosis. For purposes of clarity, the staple holder and staples havebeen omitted from FIG. 28. The system 140 includes an anvil arm 142, acutter 144, and a graft vessel holder 146 all mounted on a handle 148.The anvil arm 142 is mounted on the handle 148 and connected to a firstactuator 150 that allows the anvil to be moved downward against the biasof a spring inside the handle. The cutter 144 may be biased or fixed andis positioned on the handle 148 directly above the anvil arm 142. Thegraft vessel holder 146 includes two fixed arms 152 and two movable arms154. The two movable arms 154 are connected to a second actuator 156 onthe handle 148. Depression of the second actuator 156 against the biasof a spring within the handle causes the movable arms 154 to be moveddownward away from the fixed arms to receive portions of a graft vesselbetween the movable and fixed arms.

The operation of the system 140 of FIG. 28 is shown in the crosssectional views of FIGS. 29-31. As shown in FIG. 29, an end of a graftvessel 32 is split so that each half of the graft vessel 32 can be heldbetween a fixed arm 152 and a movable arm 154. In order to load thegraft vessel 32 into the system 140, the first actuator 150 and thesecond actuator 156 are depressed to move the anvil arm 142 and themovable arms 154 downward. The split graft vessel 32 is then insertedbetween the fixed and movable arms 152, 154 and the second actuator 156is released to trap the ends of the graft vessel 32, as shown in FIG.30. The anvil arm 142 is then inserted into the target vessel 30 in thesame or similar manner as described above.

Once the anvil has been inserted in the target vessel 30 as shown inFIG. 30, the first actuator 150 is released to allow the anvil to moveupward to tent the wall of the target vessel. FIG. 31 illustrates thetented target vessel 30 positioned adjacent the split and trapped graftvessel 32 in a position for performing anastomosis. The staple holders38 are then advanced in the direction of the arrows D toward oppositesides of the anvil to staple the graft vessel and target vesseltogether. The staple holders 38 may hold a staple strip with anexpandable backbone as shown in FIGS. 10A and 10B, or may instead oradditionally hold different types of staples not connected to abackbone. The staple holders 38 may be provided with movable pins whichallow the spacing between the staples to be adjusted depending on a sizeof the graft vessel used. Once the staples have been placed, the anvilarm 142 is removed and the cutter 144 makes an incision in the targetvessel before or during removal of the anvil.

As described above, staple bending features are provided on the anviland staples are provided at an exterior of the tissue. Alternately, thestaples and/or staple holding strips may be positioned on the anvil andan exterior member with staple bending features may be moved toward theanvil to bend the ends of the staples and secure the graft and targetvessels together.

FIGS. 32-33 illustrate the use of an alternate anvil 130 for controllingthe tissue at an anastomosis site. The anvil 130 includes a longitudinalopening 132 extending through the anvil 130 for application of aplurality of conventional sutures at the anastomosis site. According tothis method, the anvil 130 is inserted into the target vessel 30 andpulled against the interior wall of the target vessel 30, tenting thetarget vessel as shown in FIG. 33. Sutures 134 are then passed throughthe opening 132 in the anvil 130 and through the tissue of the targetvessel wall on opposite sides of the anvil 130. Once the sutures 134 areplaced as shown in FIG. 33, an incision is made in the target vesselalong a center of the anvil 130. A center portion of each of the sutures34 is then pulled out through the incision in the target vessel and cutso that an even row of sutures is provided along each of the sides ofthe incision. This system eliminates the tedious procedure of placingeach individual suture very close to the edge of the incision in thevery thin and flexible target vessel wall. Each of the sutures 134 isconnected to a graft vessel in a conventional manner completing theanastomosis. The anvil as shown in FIGS. 32-33 allows quick and easyplacement of a plurality of sutures in a very even manner close to theedge of the incision. For example, the sutures of a conventionalanastomosis are generally within about one millimeter of the edge of theincision and are advantageously within 0.5 millimeters of the edge ofthe incision.

In an alternate embodiment, the cutter 200 does not include one or moreprojections 208. Instead, the cutter 200 includes or is connecteddirectly or indirectly to an energy source (not shown), which is used tocreate an opening in the wall of the target vessel. For example, anemitter of laser or RF energy, or another type of energy, may beconnected to the cutter 200 and to the energy source. As the cutter 200translates along the anvil arm 14, it translates the emitter of laser orRF energy relative to the wall of the target vessel. The emitter oflaser or RF energy is selectively actuated to transmit energy into thewall of the target vessel during translation of the cutter 200, therebycreating an opening therein. The energy source may transmit a first typeof energy to the emitter or other mechanism, which is converted by theemitter into a second type of energy delivered into the wall of thetarget vessel. Alternately, the cutter 200 may include a projection 208and additionally be connected to an energy source that is selectivelyactuated in order to assist in creating an opening in the wall of thetarget vessel. As another example, example, the cutter 200 may be abipolar cutter or cautery tool that is movable relative to, orsubstantially fixed relative to, the anvil 10. Where the cutter 200 issubstantially fixed relative to the anvil 10, the structures andmechanisms described above for moving other exemplary cutters 200 may beomitted. Alternately, the cutter 200 may be separate from the tissueeffector 400, and may be a separate tool placed at the anastomosis sitethrough the lumen of the graft vessel 404 or through the lumen of thetarget vessel 580.

In an alternate embodiment, the cutter 200 does not translate throughthe anvil arm 14. Instead, the cutter 200 is spatially removed from theanvil arm 14, and creates an opening in the wall of the target vesselbefore or after the anvil arm 14 is inserted into the target vessel. Inone example of such an embodiment, the anvil arm 14 is inserted into ahole in the wall of the target vessel and the staple holder 38 deploysstaples or other connectors to connect the graft vessel to the targetvessel, as described above. The anvil arm 14 is removed, and anindependent cutter 200 is then introduced through the hole in the wallof the target vessel. The cutter 200 may be configured as describedabove, including a projection 208 extending therefrom, or may beconfigured differently. The cutter 200 is manipulated relative to theconnection between the target vessel and the graft vessel to create anopening at the junction therebetween. That is, registration ismaintained between the cutter 200 and the junction between the end ofthe graft vessel and the wall of the target vessel. In order to positionand manipulate the cutter 200 to create an opening at the location ofthe junction between the target vessel and the graft vessel, an imagingdevice (not shown) or other device may be connected to the cutter 200 orutilized in conjunction with the cutter 200. For example, a standardintravascular ultrasound unit may be connected to or used in conjunctionwith the cutter 200. The intravascular ultrasound unit is connected to adisplay device (not shown) visible to the operator. The operatorcontrols the intravascular ultrasound unit to visualize the interior ofthe target vessel and the surrounding area, thereby locating thejunction between the target vessel and the graft vessel and allowing thecutter 200 to be controlled to incise an opening in the wall of thetarget vessel within the closed area on the wall of the target vesseldefined by the perimeter of the end of the graft vessel, therebyallowing blood to flow through the opening into the target vessel. Adifferent visualization device or devices may be inserted into orpositioned outside of the target vessel to locate the junction with thegraft vessel. The cutter 200 and any visualization device present in thelumen of the target vessel are then removed from the lumen of the targetvessel and/or the graft vessel, and the opening in the wall of thetarget vessel through which they were removed (if any) is sealed.

In another example of such an embodiment, the anvil arm 14 is insertedinto a hole in the wall of the target vessel and the staple holder 38deploys staples or other connectors to connect the graft vessel to thetarget vessel, as described above. The anvil arm 14 is removed, and thehole in the wall of the target vessel is removed. A cannula (not shown)is inserted into the lumen of the graft vessel through the free end ofthe graft vessel, and a stylet (not shown) is inserted through the lumenof the cannula. The cannula and the stylet are surgical instruments thatare well known in the art. The stylet has a distal end configured topenetrate the wall of the target vessel. Thus, a sharp point, blade, orother penetrating member may be formed into or connected to the distalend of the stylet. The cannula may be inserted into the lumen of thegraft vessel such that its distal end contacts the outer wall of thetarget vessel. After the stylet has been inserted into the cannula, aforce is exerted on the stylet to cause its distal end to penetrate thewall of the target vessel. Consequently, an opening is created betweenthe graft vessel and the target vessel within the circumference of theend of the graft vessel. The cannula and stylet are then removed fromthe lumen of the graft vessel through its free end.

In another example of such an embodiment, the anvil arm 14 is insertedinto a hole in the wall of the target vessel and the staple holder 38deploys staples or other connectors to connect the graft vessel to thetarget vessel, as described above. The anvil arm 14 is removed, and thehole in the wall of the target vessel is closed. An independent cutter200 is then introduced through the wall of the graft vessel. The cutter200 itself may create an opening in the wall of the graft vessel throughwhich it can enter, or a separate implement may be used to create anopening in the wall of the graft vessel. The cutter 200 may beconfigured as described above, including a projection 208 extendingtherefrom, or may be configured differently. For example, the cutter 200may be J-shaped or L-shaped to facilitate creation of the openingbetween the graft vessel and the target vessel through the wall of thegraft vessel. The cutter 200 is manipulated relative to the connectionbetween the target vessel and the graft vessel to create an opening inthe wall of the target vessel at the junction therebetween. That is,registration is maintained between the cutter 200 and the junctionbetween the end of the graft vessel and the wall of the target vessel.The cutter 200 is then removed through the wall of the graft vessel, andthe opening in the wall of the graft vessel is sealed.

In an alternate embodiment, at least the anvil arm 14 portion of theanvil 10 is expandable from a first, narrower configuration to a second,wider configuration. Consequently, the anvil arm 14 can be inserted intothe lumen of the target vessel 580 through the anvil entry hole 584 inthe first configuration, expanded to the second configuration, and thencollapsed back to the first configuration for removal through the anvilentry hole 584. In this way, the size of the anvil entry hole 584 may beminimized. As a result, the sealer 780 may be smaller, or omittedaltogether. The anvil arm 14 and/or anvil 10 may be fabricated in anysuitable manner to allow for its transition between first and secondconfigurations. As one example, the anvil arm 14 may be inflatable fromthe first configuration to the second configuration. The anvil arm 14may be made from, coated with, attached to or otherwise associated witha material strong enough to allow gas to inflate it to a substantiallyrigid state, and/or to allow the connectors 464 to be deflected uponcontact with the surface of the inflatable anvil arm 14. For example,the anvil arm 14 may be made from, or coated with, KEVLAR® brand fiber.As another example, metallic strips, panels or other elements may beattached to the anvil arm 14 at locations where the connectors 464contact the anvil arm 14, such that those metallic elements engage thetines 466 of the connectors. The anvil arm 14 may be otherwisefabricated to move between first and second configurations. For example,the anvil arm 14 may be a truss, linkage or other mechanism that ismovable from a first, narrower configuration to a second, widerconfiguration.

In an alternate embodiment, more than one anvil arm 14, or an anvil arm14 having two or more components, is utilized. As one example, the anvilarm 14 may be bifurcated. In such an embodiment, the cutter 200 slidesbetween the bifurcations of the anvil arm 14. The cutter 200 need not beconnected to the anvil arm 14, and may be slid out of the heel 587 ofthe anastomosis after the arteriotomy has been completed. As anotherexample, two or more separate anvil arms 14 are inserted into the lumenof the target vessel 580 via the anvil entry hole 584, at the same timeas one another or at different times. As another example, at least oneanvil arm 14 is inserted into the lumen of the target vessel 580 via theanvil entry hole 584, and at least one anvil arm 14 is positionedoutside the target vessel 580. The anvil arms 14 may be moved toward oneanother to clamp the tissue of the wall of the target vessel 580 betweenthem. Optionally, the cutter 200 may be associated with the anvil arm 14outside the target vessel 580, rather than the anvil arm 14 inside thetarget vessel 580. After completing the anastomosis, the anvil arm 14outside the target vessel 580 may be removed from the anastomosis sitevia the heel 587.

In an alternate embodiment, the anvil 10 is not part of the anastomosistool 300. Instead, an external anvil (not shown) is positioned at or inproximity to the exit of each connector bay 448. Each external anvil maybe a tab or other structure or mechanism. As each connector 464 is urgedout of the corresponding connector bay 448, that connector 464encounters the corresponding external anvil 448. Contact between theconnector 464 and the external anvil causes the connector 464 to deform.This deformation deflects the tines 466 of the connectors 464, such thatthe connectors 464 deform to a position in which they hold thecorresponding flap 408 to the target vessel 580. The staple holder 38 islater pulled away from the anastomosis, and each external anvil slidesout from underneath the base 468 of the corresponding connector 464.

In an alternate embodiment, the anvil 10 is not part of the anastomosistool 300. The connectors 464 are composed of superelastic material, orare otherwise fabricated and/or configured, such that they aredeployable without the use of an anvil 10 or an external anvil oranvils. For example, where the connectors 464 are superelastic, they maybe held in a first position under a restraining force. To deploy theconnectors 464, they may be placed against the corresponding flap 408,after which the restraining force on the connectors 464 is released. Thesuperelastic connectors 464 then self-deform to connect the flap orflaps 408, without the need for an anvil 10. As another example, theconnectors 464 are deployed so quickly that a backing such as the anvil10 is not needed. The connectors 464 are advanced into the wall of thetarget vessel 580 fast enough such that the blood or other fluid in thetarget vessel 580 acts as a solid and supports the wall of the targetvessel 580 against the advance of the connectors 464. That is, theconnectors 464 advance into the wall of the target vessel 580 fastenough that the fluid within substantially does not have time to move inresponse to the motion of the connectors 464, such that the fluid actsas if it were a solid. To accomplish this effect, the connectors 464 mayadvance at a rate of substantially 0.8-1.4 msec. Thus, the connectors464 may be deployed without the use of the anvil 10. Where the anvil 10is not used, the anastomosis tool 300 may be configured more simply. Asone example, the staple holder 38 is pressed against a flap 408 of thegraft vessel 404 after the flap 408 has been placed on the target vessel580. The staple holder 38 is then actuated. The staple holder 38 mayinclude a single arm 402, in which case a different single-use stapleholder 38 may be utilized for each flap 408, or the same reusable stapleholder 38 may be reloaded and then utilized for more than one flap 408.

In an alternate embodiment, the staple holder 38 includes a single arm402. The single arm 402 is movable from one side of the anastomosis siteto the other to perform part of the anastomosis at a time. For example,where two flaps 408 are formed at the end of the graft vessel 404, thesingle arm 402 may deploy at least one connector 464 to connect one flap408 to the target vessel 580, then move to the other side of the graftvessel 404 to deploy at least one connector 464 to connect the otherflap 408 to the target vessel 580. The anvil arm 14 may be left in placewhile the single arm 402 sequentially deploys the connectors 464 atdifferent locations. The cutter 200 and/or projection 208 may beactuated to create an opening in the wall of the target vessel 580 atany suitable time. For example, the cutter 200 and/or projection 208 maybe actuated after the single arm 402 has deployed all of the connectors464 needed to complete the anastomosis. The sled 482 may be configuredand/or actuated to sequentially deploy one or more connectors 464 atdifferent times and locations. Alternately, any other suitable mechanismmay be utilized to deploy one or more connectors 464 at different timesand locations.

In an alternate embodiment, the connectors 464 may be deployed from thestaple holder 38 using ultrasonic or piezoelectric energy. Theconnectors 464 may be held in the connector bays 448 as described above,or may be held in a different manner by the arms 402. Optionally, theconnector deployer 452 may be omitted from at least one connector bay448. Where ultrasonic deployment is used, ultrasonic energy is appliedto the connectors 464 in any suitable manner. For example, at least oneultrasonic transmitter may be located in the staple holder 38 adjacentto or in proximity to each connector 464. Application of ultrasonicenergy to the connectors 464 causes each connector 464 to move out ofthe staple holder 38, through the corresponding flap 408, then into thewall of the target vessel 580. The frequency of the ultrasonic energyapplied to the connectors 464 causes the connectors 464 to vibrate asthey advance through tissue, facilitating their deployment. Wherepiezoelectric deployment is used, one or more piezoelectric emitters maybe located in the staple holder 38 adjacent to or in proximity to eachconnector 464. Actuation of the piezoelectric emitter or emitters causeseach connector 464 to vibrate and move out of the staple holder 38,through the corresponding flap 408, then into the wall of the targetvessel 580. The vibration of the connectors 464 as they advance throughtissue facilitates their deployment. Alternately, the connectordeployers 452 are utilized, and actuation of an ultrasonic transmitteror piezoelectric emitter causes the connector deployers 452 to urge theconnectors 464 out of the connector bays 448. If so, the sled 482 or theramp elements 446 of the sled 482 may be omitted.

In an alternate embodiment, the tissue effector 400 may be used toperform a side-to-side anastomosis. At least part of the staple holder38 is sized to fit into the lumen of the graft vessel 404 through an endthereof. Where the tissue effector 400 is used to perform a side-to-sideanastomosis, the staple holder 38 is not detachable from the remainderof the tissue effector 400 or from any other part of the anastomosistool 300; that is, the staple holder 38 is not a cartridge. After atleast part of the staple holder 38 is placed into the lumen of the graftvessel 404 through an end thereof, the anastomosis procedure continuessubstantially as described above. The cutter 200 and/or projection 208is sized and/or shaped to cut through both the wall of the target vessel580 and the wall of the graft vessel 404, to allow fluid to flowtherebetween. After the anastomosis is complete, the staple holder 38 isremoved from the lumen of the graft vessel 404 through the end thereof.That end of the graft vessel 404 is then closed in any suitable manner,such as by suturing, stapling or clipping.

In an alternate embodiment, the graft vessel 404 is connected to thecutter 200, rather than the staple holder 38. Advantageously, the graftvessel 404 is connected to a proximal portion of the cutter 200, such asby a spike, clip and/or other structure or mechanism. However, the graftvessel 404 may be attached, directly or indirectly, to any other part ofthe cutter 200. As the cutter 200 creates the arteriotomy in the targetvessel 580, it pulls the end of the graft vessel 404 over thearteriotomy. The connectors 464 are then deployed to connect the end ofthe graft vessel 404 to the target vessel 580. That is, the arteriotomyis created before the connectors 464 are deployed.

With reference now to FIG. 166A, in another embodiment, a surgicalstapler for aortic anastomosis 1200 may include a handle 1210 with anactuator 1220 and safety switch 1230, an optional rigid shaft 1245 fromthe handle, a flexible shaft 1240 extending from the rigid shaft, ananvil 1250 at the distal end of the flexible shaft 1240, and an anvilguidewire 1260 extending beyond the anvil 1250 and including a pointeddistal tip 1265. In an alternative embodiment, all of the shaft may beflexible. FIG. 166B illustrates a stapler cartridge 1270 for use withthe stapler 1200, including graft clamps 1310. Both the stapler 1200 andthe cartridge 1270 may include any of the features described above inrelation to various alternative embodiments. Some features unique tothis embodiment are described in further detail below. In general, theanvil guidewire 1260 is used to pierce into an aorta and hold thestapler 1200 in position relative to the aorta during an anastomosisprocedure. The stapler cartridge 1270 can be loaded onto and removedfrom the anvil 1250 while the guidewire 1260 remains in position withinan anastomosis. Thus, the anvil guidewire 1260 helps facilitate anaortic anastomosis procedure by helping maintain position of the stapler1200 even in the high flow, high pressure, large diameter environment ofthe aorta.

In various embodiments, the rigid shaft 1245, the flexible shaft 1240,the anvil 1250 and the anvil guidewire 1260 may each have any suitablelength and may, together, have any suitable total length. The anvilguidewire 1260, for example, will typically have a length that issufficiently long to allow it to pass into the aorta and help stabilizethe stapler 120 relative to the aorta during use. In variousembodiments, for example, the anvil guidewire 1260 may have a length ofbetween about 2 cm and about 20 cm. The anvil guidewire 1260 may be madeof any suitable material, such as stainless steel, Nitinol or the like,and may have the pointed tip 1265 for piercing into the aorta. As willbe described in further detail below, the anvil guidewire 1260 isconfigured to enter the aorta at a first location, for anchoring thestapler 1200, and the anvil 1250 and cartridge 1270 are then used tocreate the anastomosis between a graft and the aorta at a secondlocation apart from the first location. Separating the aorta entry sitefrom the anastomosis sight may be advantageous, for example because itmay typically be easier to close the entry site, using a purse stringsuture or other method, if the entry site is separate. Furthermore,entering the aorta by puncturing through the aortic wall with thepointed distal tip 1265 of the guidewire 1260 is generally less invasivethan forming an incision in the aorta, thus making closure of the aortaeasier.

The cartridge 1270 may include one or more optional, advantageousfeatures, some of which may be configured to address the challenges offorming an astomosis between a graft and an aorta. For example, in oneembodiment, the cartridge 1270 may house four rows of staples ratherthan the usual two rows. In such an embodiment, two of the four rows ofstaples may be positioned close together on one side of an opening inthe cartridge through which a cutter passes, and the other two rows ofstaples may be positioned close together on the other side of theopening. In another embodiment, staples may be configuredcircumferentially.

Referring now to FIG. 167, in one embodiment, a system for aorticanastomosis may include a graft loader 1280, which couples with thestaple cartridge 1270 to load the graft onto the cartridge 1270. In oneembodiment, the graft loader 1280 may include a graft piercer 1300,which pierces and temporarily holds the graft in place, relative to thecartridge 1270, until the graft clamps 1310 are closed to hold the graftto the cartridge 1270. Various additional features of the graft loader1280 are described in greater detail below.

With reference now to FIGS. 168A-168E, a method for loading a graft ontothe cartridge 1270 using the graft loader 1280 is illustrated, accordingto one embodiment. For clarity, the method is illustrated without agraft, so that various component parts of the cartridge 1270 and thegraft loader 1280 may be more easily seen. Generally, the graft may beany suitable graft, such as a synthetic or human tissue graft. Referringto FIG. 168A, as a first step, the cartridge 1270 may be coupled withthe loader 1280. This coupling may be achieved sliding or clipping thecartridge 1270 into the loader 1280 via a snap fit, pressure fit or thelike. As shown in FIG. 168B, a next step may be to evert the graft overa heel staple 1290. The heel staple 1290, as described previously, is astaple at one end of the cartridge 1270, which bridges between two rowsof staples at the far end of the two rows, thus forming a closure at oneend of the two rows of staples once deployed. Next, as shown in FIG.168C, the piercer 1300 may be used to pierce the graft onto the heelstaple 1290, thus holding the graft in place until the graft clamps 1310of the cartridge 1270 are closed. Referring now to FIG. 168D, the graftclamps 1310 may next be closed, thus holding the graft in place on thecartridge 1270. In this embodiment, the cartridge 1270 also includes anoptional shield 1320. Finally, as shown in FIG. 168E, the cartridge 1270is removed from the loader 1280, with the graft clamps 1310 holding thegraft in place. Before the cartridge 1270 is removed form the loader1280, the piercer 1300 is raised up to allow the cartridge 1270 to exitthe loader 1280 freely. In various alternative embodiments, loading ofthe graft 1340 onto the cartridge 1270 may be performed by a physician,physician's assistant or the like (i.e., the user) or may be preloadedby a manufacturer.

Referring to FIG. 169, the loader 1280 is shown, with the piercer 1300raised for release of the cartridge 1270. In this figure, a graft 1340is shown in position on the cartridge 1270, with the graft clamps 1310lowered to hold the graft 1340 in place.

With reference now to FIGS. 170A-170J, a method for using the aorticanastomosis stapler 1200 to form an aorta/graft anastomosis, accordingto one embodiment, will be described. FIG. 170A shows a portion of anaorta A, to which a purse string suture 1330 has been applied. FIG. 170Billustrates the anvil guidewire 1260 with its pointed distal tip 1265.The pointed distal tip 1265 may be used to puncture through the wall ofthe aorta A, within the circumference of the purse string suture 1330.As shown in FIGS. 170C and 170D, the guidewire 1260 may then be advancedinto the aorta A until the anvil 125 abuts the wall of the aorta A.

Referring now to FIG. 170E, the anvil 1250 is now in place next to theaorta A, with the anvil guidewire 1260 inside the aorta A (and thus notvisible in the figure). The flexible shaft 1240 extends proximally fromthe anvil 1250, to the handle 1210 (not shown), which will be held bythe physician or physician's assistant. At this point, the cartridge1270, holding the graft 1340, may be attached to the anvil 1250. (In analternative embodiment, the cartridge 1270 may be preloaded onto theanvil 1250.) FIG. 170F shows the cartridge 1270 loaded onto the anvil1250 and ready for deployment of staples. At this point, staples may bedeployed by, for example, pressing the actuator 1220 on the handle 1210once to clamp the cartridge 1270 onto tissue and a second time to firethe staples. Methods for staple deployment are described more fullyabove.

As illustrated in FIGS. 170G and 170H, once the staples are deployed,thus attaching the graft 1340 to the aorta A, the cartridge 1270 may beremoved, thus leaving the completed anastomosis 1350 between the graft1340 and the aorta A. As illustrated in these figures, the guidewire1260 (not visible) is inserted into the aorta A at a first location(within the purse string suture circumference in this embodiment), andthe anastomosis 1350 is formed at a second, separate location on theaorta A. The separation of the entry point (first location) from theanastomosis 1350 (second location) may be advantageous, in that it willbe easier to close the entry hole at a first, separate location than itwould be if the hole were within the anastomosis. In various alternativeembodiments, the first and second locations may be separated by anysuitable distance, such as anywhere from several millimeters to severalcentimeters. In some embodiments, the separation may be at least about 1centimeter. In some cases, it may be necessary or desired to deployadditional staples, in which case, a new cartridge may be attached tothe anvil 1250 for deployment of the additional staples.

With reference now to FIG. 1701, once the anastomosis 1350 has beenformed, the anvil guidewire 1260 may be removed from the aorta A. Asillustrated in FIG. 170J, during and/or after removal of the anvilguidewire 1260, the purse string suture 1330 may be tightened (or“cinched”), thus closing the puncture formed in the aorta A by theguidewire 1260. In this way, an aortic anastomosis may be formed in arelatively minimally invasive and simple procedure.

In alternative embodiments, the above-described surgical stapler 1200and method may be used to form an anastomosis on another large diameterblood vessel, other than the aorta. For example, the surgical stapler1200 may be used on a femoral artery in one alternative embodiment.Thus, the method described above is not limited exclusively toanastomosis formation on the aorta.

While the invention has been described in detail, various changes andmodifications can be made and equivalents employed, without departingfrom the present invention. It is to be understood that the invention isnot limited to the details of construction, the arrangements ofcomponents, and/or the process of performing anastomosis set forth inthe above description or illustrated in the drawings. Further, theinvention is not limited to the performance of anastomosis in thecontext of an aortic grafting procedure or CABG procedure, nor it islimited to the anastomosis of two bodily vessels. Other tissuestructures than vessels may be connected together within the bodyutilizing the present invention. Statements in the abstract of thisdocument, and any summary statements in this document, are merelyexemplary; they are not, and cannot be interpreted as, limiting thescope of the claims. Further, the figures are merely exemplary and notlimiting. Topical headings and subheadings are for the convenience ofthe reader only. They should not and cannot be construed to have anysubstantive significance, meaning or interpretation, and should not andcannot be deemed to indicate that all of the information relating to anyparticular topic is to be found under or limited to any particularheading or subheading. Therefore, the invention is not to be restrictedor limited except in accordance with the following claims and theirlegal equivalents.

What is claimed is:
 1. A method for connecting a graft vessel to atarget vessel, the method comprising: advancing a guidewire, attached toand extending from an anvil of a surgical stapler, into the targetvessel through an opening at a first location on the target vessel;coupling a stapler cartridge carrying the graft vessel with the anvil ofthe surgical stapler; activating the anvil to staple the graft vessel tothe target vessel at a second location on the target vessel, apart fromthe first location; removing the guidewire from the target vessel; andclosing the opening in the target vessel, wherein closing the openingcomprises cinching a purse string suture previously placed in the targetvessel around the first location.
 2. The method as in claim 1, furthercomprising, piercing the target vessel at the first location to form theopening, prior to advancing the guidewire, using a pointed distal tip ofthe guidewire.
 3. The method as in claim 2, further comprising, forminga purse string suture in the target vessel around the first location,prior to piercing the target vessel, wherein closing the openingcomprises cinching the purse string suture.
 4. The method as in claim 1,wherein the target vessel comprises an aorta.
 5. The method as in claim1, wherein the advancing step comprises advancing the guidewire untilthe anvil of the surgical stapler contacts the target vessel.
 6. Themethod as in claim 1, further comprising loading the graft onto thecartridge, using a graft loading device, before coupling the cartridgewith the anvil.
 7. The method as in claim 1, wherein activating theanvil causes two rows of staples to be deployed to staple the graftvessel to the target vessel.
 8. The method as in claim 1, whereinactivating the anvil causes four rows of staples to be deployed tostaple the graft vessel to the target vessel.
 9. The method as in claim1, further comprising stabilizing the surgical stapler relative to thetarget vessel, using the guidewire.
 10. The method as in claim 1,wherein the first location and the second location are separated by atleast about 1 cm.
 11. The method as in claim 1, further comprising,removing the cartridge from the anvil.
 12. The method as in claim 11,further comprising: attaching another cartridge to the anvil; andactivating the anvil to further staple the graft vessel to the targetvessel.
 13. The method as in claim 1, wherein the guidewire remains inposition in the target vessel during the coupling the stapler cartridgecarrying the graft vessel with the anvil.
 14. The method as in claim 1,wherein the guidewire is inside the target vessel while the anvil isactivated to staple the graft vessel to the target vessel.
 15. Themethod as in claim 1, further comprising, replacing the staplercartridge with a further stapler cartridge, prior to the removing theguidewire and the closing the opening.
 16. The method as in claim 1,wherein the first location on the target vessel is separated by adistance from an anastomosis formed by the graft vessel stapled to thetarget vessel at the second location on the target vessel.
 17. A methodfor connecting a graft vessel to a target vessel, the method comprising:advancing a guidewire, attached to and extending from an anvil of asurgical stapler, into the target vessel through an opening at a firstlocation on the target vessel, wherein advancing the guidewire throughthe opening at the first location on the target vessel includesadvancing an entirety of the guidewire into an interior of the targetvessel; coupling a stapler cartridge carrying the graft vessel with theanvil of the surgical stapler; activating the anvil to staple the graftvessel to the target vessel at a second location on the target vessel,apart from the first location; removing the guidewire from the targetvessel; and closing the opening in the target vessel, wherein closingthe opening comprises cinching a purse string suture previously placedin the target vessel around the first location.